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The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers.
Shibata, M, Toyoshima, J, Kaneko, Y, Oda, K, Kiyota, T, Kambayashi, A, Nishimura, T
Clinical pharmacology in drug development. 2021;(3):283-290
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Abstract
The marketed tablet formulation of peficitinib differs from the tablet used during the clinical trials. The bioequivalence of the marketed formulation and developmental tablet, and the food effect on the marketed formulation, were analyzed in 2 Japanese open-label, randomized, 2-way crossover studies in healthy male volunteers. Volunteers received a single oral dose of the marketed 150-mg peficitinib tablet under fasted conditions (bioequivalence), and under fed or fasted conditions (food effect). Bioequivalence was compared with the developmental 150-mg tablet. Samples for pharmacokinetic analysis were collected before dose and ≤72 hours after dose. Safety assessments included adverse events, vital signs, and laboratory variables. In total, 40 and 18 subjects were randomized to the bioequivalence and food effect studies, respectively. The 2 peficitinib formulations were bioequivalent (90% confidence intervals of the geometric mean ratios for Cmax and AUCt of peficitinib were within predefined limits of 0.8 to 1.25). The AUClast and the Cmax of the marketed tablet were 36.8% and 56.4% higher, respectively, under fed versus fasted conditions. Peficitinib was well tolerated. The marketed 150-mg tablet formulation of peficitinib was bioequivalent to the developmental 150-mg formulation, with no discernible safety differences. Bioavailability increased under fed conditions with the marketed tablet formulation.
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Effects of Food and Gender on Pharmacokinetics of Rosuvastatin in a Chinese Population Based on 4 Bioequivalence Studies.
Chen, J, Lou, H, Jiang, B, Shao, R, Yang, D, Hu, Y, Xu, Y, Ruan, Z
Clinical pharmacology in drug development. 2020;(2):235-245
Abstract
The effects of food and gender on the pharmacokinetics of rosuvastatin in healthy Chinese subjects were investigated from 4 bioequivalence studies. These studies were designed as randomized, open-label, and 2-period crossover in both fasting and fed states. A total of 204 subjects were enrolled, 134 men and 70 women. These subjects received a single oral 10-mg dose of rosuvastatin with a 7-day washout between 2 periods. The plasma concentrations were determined using a validated liquid chromatography tandem mass spectrometry method, and pharmacokinetic parameters were calculated by noncompartmental methods. Compared with the fasting condition, administration after a high-fat and high-calorie meal resulted in an approximately 40% reduction of rosuvastatin exposure and a near 50% decrease in absorption rate. Moreover, the apparent clearance was significantly greater in the fed state than that in the fasting state. It was noted that the adverse events incidence is increased by approximately 30% in the fasting state; however, no serious adverse events were observed. Additionally, small differences in pharmacokinetic characteristics were found between male and female subjects. Food effect might be considered for optimal effectiveness and safety of rosuvastatin therapy.
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The effects of nudging and pricing on healthy food purchasing behavior in a virtual supermarket setting: a randomized experiment.
Hoenink, JC, Mackenbach, JD, Waterlander, W, Lakerveld, J, van der Laan, N, Beulens, JWJ
The international journal of behavioral nutrition and physical activity. 2020;(1):98
Abstract
BACKGROUND Evidence on what strategies - or combination of strategies - are most effective and equitable in promoting healthier diets is needed. This study examined the efficacy of nudging and pricing strategies on increasing healthy food purchases and the potential differential effect by socio-economic position (SEP) among Dutch adults in a virtual supermarket. METHODS A randomized study design was conducted within a virtual supermarket (SN VirtuMart). Participants were exposed to five within-subject study conditions (control, nudging, pricing, price salience and price salience with nudging) and randomized to one of three between-subject study arms (a 25% price increase on unhealthy products, a 25% discount on healthy products, or a 25% price increase and discount). In total, 455 participants of low and high SEP (using either education or income as proxy) were randomized to conduct their weekly shopping in a virtual supermarket for five consecutive weeks. The primary outcome included the percentage of healthy purchases. Data were analyzed using linear mixed models. RESULTS In total, 346 (76%) adults completed all five shops within the SN VirtuMart. Median age was 32.5, 49.2% had high education and 32.8% had high income. Out of the 12 conditions, four conditions were statistically significantly different from the control condition. Nudging and non-salient pricing strategies alone did not statistically significantly increase healthy food purchases, whereas a combination of salient price increases and discounts led to an increase in the percentage of healthy food purchases (B 4.5, 95%CI 2.6; 6.4). Combining salient pricing and nudging strategies led to increases in the percentage of healthy products in all three pricing arms, with largest effects found in the combined price increase and discount arm (B = 4.0, 95%CI = 2.0; 6.0). Effects were not modified by SEP. CONCLUSIONS Combining health-related price increases and discounts and combining these salient pricing strategies with nudges in a supermarket setting seems to stimulate healthy food purchases for both low and high SEP populations. However, further research in real-world settings is needed. TRIAL REGISTRATION This randomized trial ( NTR7293 ) was registered in the Dutch trial registry ( www.trialregister.nl ).
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Can counter-advertising diminish persuasive effects of conventional and pseudo-healthy unhealthy food product advertising on parents?: an experimental study.
Dixon, H, Scully, M, Gascoyne, C, Wakefield, M
BMC public health. 2020;(1):1781
Abstract
BACKGROUND To help address rising rates of obesity in children, evidence is needed concerning impacts of common forms of marketing for unhealthy child-oriented food products and the efficacy of educational interventions in counteracting any detrimental impacts of such marketing. This study aims to explore parents' responses to advertising for unhealthy children's food products that employ different types of persuasive appeals and test whether a counter-advertising intervention exposing industry motives and marketing strategies can bolster parents' resistance to influence by unhealthy product advertising. METHODS N = 1613 Australian parents were randomly assigned to view online either a: (A) non-food ad (control); (B) conventional confectionery ad (highlighting sensory benefits of the product); (C) pseudo-healthy confectionery ad (promoting sensory benefits and health attributes of the product); (D) conventional confectionery ad + counter-ad (employing inoculation-style messaging and narrative communication elements); (E) pseudo-healthy confectionery ad + counter-ad. Parents then viewed various snacks, including those promoted in the food ads and counter-ad. Parents nominated their preferred product, then rated the products. RESULTS Exposure to the conventional confectionery ad increased parents' preference for the advertised product, enhanced perceptions of the product's healthiness and reduced sugar content and boosted brand attitude. Exposure to the pseudo-healthy confectionery ad increased parents' preference for the advertised product, and enhanced perceptions of healthiness, fibre content and lower sugar content. The counter-ad diminished, but did not eliminate, product ad effects on parents' purchasing preference, product perceptions and brand attitudes. The counter-ad also prompted parents to perceive processed foods as less healthy, higher in sugar and lower in fibre and may have increased support for advertising regulation. CONCLUSIONS Exposure to unhealthy product advertising promoted favourable perceptions of products and increased preferences for advertised products among parents. Counter-advertising interventions may bolster parents' resistance to persuasion by unhealthy product advertising and empower parents to more accurately evaluate advertised food products.
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Effect of Food on the Pharmacokinetics of Quizartinib.
Li, J, Holmes, M, Kankam, M, Trone, D, Mendell, J, Gammon, G
Clinical pharmacology in drug development. 2020;(2):277-286
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Abstract
Quizartinib is an oral, highly potent, and selective type II FMS-like tyrosine kinase 3 inhibitor in development for acute myeloid leukemia. This parallel-group study evaluated potential food effects on quizartinib absorption in healthy subjects who received a single 30-mg dose after overnight fasting (n = 34) or a high-fat, high-calorie meal (n = 30). Blood samples were collected through 504 hours after dosing, and pharmacokinetic parameters calculated were maximum observed concentration (Cmax ) and area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast ) and from time 0 to infinity (AUCinf ). Mean quizartinib pharmacokinetic profiles were similar under fasted and fed conditions. The geometric least squares means ratios (%) for fed/fasted and associated 90% confidence intervals (CIs) for Cmax , AUClast , and AUCinf were 91.58 (82.15-102.08), 105.39 (90.79-122.35), and 108.39 (91.54-128.34), respectively. The 90%CI for the ratio fell within the 80% to 125% limits for Cmax and AUClast , with 90%CI for AUCinf slightly outside the limits (ie, 128%). Food delayed quizartinib time to Cmax by 2 hours. All adverse events were either mild or moderate; no discontinuations due to adverse events occurred. Based on these results, quizartinib can be administered without regard to food.
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The effect of implicit and explicit taxes on the purchasing of 'high-in-calorie' products: A randomized controlled trial.
Doble, B, Ang Jia Ler, F, Finkelstein, EA
Economics and human biology. 2020;:100860
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Abstract
Public health taxes on less healthy food and beverage products have been shown to be effective in various settings. However, it is unclear if observed reductions in the quantity of taxed products purchased is a result of price increases due to the tax or the accompanying messaging and if the effects are influenced by the level of support for such taxes within the population. 941 adults residing in Singapore were randomized and asked to shop in one of four versions of a fully functional on-line experimental grocery store: 1) no tax control; 2) implicit tax showing only post-tax prices (i.e., 20 % higher than control prices) on high-in-calorie products; 3) fake tax showing pre-tax prices and a label falsely indicating that the price includes a 20 % tax on high-in-calorie products; and 4) explicit tax showing the same label as in 3) and an actual 20 % price increase applied to the high-in-calorie products. The proportion of high-in-calorie products purchased was 14 % in the control arm. We were unable to reject the null hypothesis of no effect in the implicit tax arm compared to control (0.08, 95 % CI -3.31 to 1.77) or in the fake tax arm compared to the control (2.59, 95 % CI -5.04 to 0.00) but observed a statistically significant 3.35 percentage point decrease (95 % CI -6.01 to -0.5) in the explicit tax arm compared to control. We were unable to reject the null hypothesis of no effect in any of the outcomes related to diet quality. Individuals who support the tax showed greater responsiveness to the explicit and fake taxes compared to those who do not (price elasticities of demand of -1.38 and -0.51 respectively). Results suggest that reductions in the proportions of high-in-calorie products purchased may be largely attributable to explicit messaging rather than to price increases. However, even when effective, policymakers should recognize that changes in purchasing patterns may not improve diet quality and that results may not generalize to other areas where levels of support differ.
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Bioequivalence and Food Effect Assessment of 2 Fixed-Dose Combination Formulations of Dolutegravir and Lamivudine.
Dumitrescu, TP, Peddiraju, K, Fu, C, Bakshi, K, Yu, S, Zhang, Z, Tenorio, AR, Spancake, C, Joshi, S, Wolstenholme, A, et al
Clinical pharmacology in drug development. 2020;(2):189-202
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Abstract
This single-dose study evaluated the bioequivalence, food effect, and safety of 2 experimental, 2-drug, fixed-dose formulations of 50 mg dolutegravir and 300 mg lamivudine (formulation AH and formulation AK) as compared with coadministration of single-entity tablets of 50 mg dolutegravir and 300 mg lamivudine (reference). In fasted subjects, formulation AH lamivudine exposure was similar to the reference; however, dolutegravir exposure was consistently higher in formulation AH, with area under the concentration-time curve (AUC) and maximum concentration (Cmax ) approximately 27% to 28% greater than reference. Formulation AK met bioequivalence standards to the reference for dolutegravir (AUC0-∞ and Cmax ) and lamivudine (AUC0-∞ and AUC0-t ) exposure; however, dolutegravir AUC0-t and lamivudine Cmax were approximately 16% and 32% higher than the reference, respectively. A high-fat meal increased dolutegravir AUC and Cmax by up to 33% and 21%, respectively, and decreased lamivudine Cmax by approximately 30%. Both test and reference formulations were well tolerated. The results support further development of formulation AK as a novel, 2-drug, fixed-dose combination tablet treatment for patients with HIV.
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Increasing low-energy-dense foods and decreasing high-energy-dense foods differently influence weight loss trial outcomes.
Vadiveloo, M, Parker, H, Raynor, H
International journal of obesity (2005). 2018;(3):479-486
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BACKGROUND/OBJECTIVE Although reducing energy density (ED) enhances weight loss, it is unclear whether all dietary strategies that reduce ED are comparable, hindering effective ED guidelines for obesity treatment. This study examined how changes in number of low-energy-dense (LED) (<4.186 kJ/1.0 kcal g-1) and high-energy-dense (HED) (>12.56 kJ/3.0 kcal g-1) foods consumed affected dietary ED and weight loss within an 18-month weight loss trial. METHODS This secondary analysis examined data from participants randomized to an energy-restricted lifestyle intervention or lifestyle intervention plus limited non-nutrient dense, energy-dense food variety (n=183). Number of daily LED and HED foods consumed was calculated from three, 24-h dietary recalls and anthropometrics were measured at 0, 6 and 18 months. Multivariable-adjusted generalized linear models and repeated-measures mixed linear models examined associations between 6-month changes in number of LED and HED foods and changes in ED, body mass index (BMI), and percent weight loss at 6 and 18 months. RESULTS Among mostly female (58%), White (92%) participants aged 51.9 years following an energy-restricted diet, increasing number of LED foods or decreasing number of HED foods consumed was associated with 6- and 18-month reductions in ED (β=-0.25 to -0.38 kJ g-1 (-0.06 to -0.09 kcal g-1), P<0.001). Only increasing number of LED foods consumed was associated with 6- and 18-month reductions in BMI (β=-0.16 to -0.2 kg m-2, P<0.05) and 6-month reductions in percent weight loss (β=-0.5%, P<0.05). Participants consuming ⩽2 HED foods per day and ⩾6.6 LED foods per day experienced better weight loss outcomes at 6- and 18-month than participants only consuming ⩽2 HED foods per day. CONCLUSION Despite similar reductions in ED from reducing number of HED foods or increasing number of LED foods consumed, only increasing number of LED foods related to weight loss. This provides preliminary evidence that methods used to reduce dietary ED may differentially influence weight loss trajectories. Randomized controlled trials are needed to inform ED recommendations for weight loss.
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A Default Option to Enhance Nutrition Within Financial Constraints: A Randomized, Controlled Proof-of-Principle Trial.
Coffino, JA, Hormes, JM
Obesity (Silver Spring, Md.). 2018;(6):961-967
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OBJECTIVE This study aimed to examine the feasibility and initial efficacy of a novel default option intervention targeting nutritional quality of online grocery purchases within the financial constraints of food insecurity. METHODS Female undergraduates (n = 59) without eating disorder symptoms or dietary restrictions selected foods online with a budget corresponding to maximum Supplemental Nutrition Assistance Program benefits. Before completing the task again, participants were randomly assigned to receive a $10 incentive for selecting nutritious groceries (n = 17), education about nutrition (n = 24), or a default online shopping cart containing a nutritionally balanced selection of groceries (n = 18) to which they could make changes. Nutritional quality was quantified by using the Thrifty Food Plan Calculator. RESULTS Compared with the education condition, participants in the default condition selected significantly more whole grains and fruits and foods lower in cholesterol, saturated fats, sodium, and overall calories. There were no statistically significant differences in nutritional outcomes between the incentive condition and the other two groups. CONCLUSIONS Findings provide initial support for the efficacy of a default option in facilitating healthier food choice behaviors within financial constraints.
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The absolute bioavailability and the effect of food on a new magnesium lactate dihydrate extended-release caplet in healthy subjects.
Dogterom, P, Fu, C, Legg, T, Chiou, YJ, Brandon, S
Drug development and industrial pharmacy. 2018;(9):1481-1487
Abstract
OBJECTIVE To assess the absolute bioavailability of 20 mEq magnesium lactate extended-release (ER) caplets and to assess the effect of food on the pharmacokinetics of these ER caplets. SIGNIFICANCE Magnesium in different salt forms is available as over-the-counter oral formulations. The absorption and bioavailability is highly affected by the water solubility of the salt form. A new ER caplet of 10 mEq strength of magnesium L-lactate dihydrate has been developed to increase the bioavailability of magnesium. METHODS An open label, single-dose, randomized, three-period, cross-over study in healthy adults was conducted with three treatments: (a) single oral dose of 20 mEq magnesium L-lactate dehydrate under fasting conditions, (b) single intravenous (IV) infusion of 20 mEq magnesium sulfate, and (c) single oral dose of 20 mEq magnesium L-lactate dehydrate under fed conditions. Urine and blood samples were collected for analysis of urinary and serum magnesium concentrations. RESULTS Absolute bioavailabilities of the caplets under fasted and fed conditions, compared to IV magnesium sulfate, were 20.26% (fasted) and 12.49% (fed) in serum, based on the geometric mean ratio (GMR) of the baseline-adjusted AUC0-72, and 38.11% (fasted) and 40.99% (fed) in urine, based on the GMR of the baseline-adjusted Ae0-72. Relative bioavailability of the caplets comparing the fed and fasted states was 61.67% in serum, based on the GMR of the baseline-adjusted AUC0-72, and 107.57% in urine, based on the GMR of the baseline-adjusted Ae0-72. CONCLUSIONS This new magnesium formulation has reasonable bioavailability and might be a valuable addition to the currently available magnesium oral products.