ABSTRACT
Since the impact of food on innovative drugs exposure will increase the risk of evaluation failures for safety and effectiveness, food effect study is routinely completed before multiple ascending dose (MAD) trials for innovative drugs. The prediction performance of physiologically-based pharmacokinetic absorption model (absorption PBPK model) in the application of food effect prediction has improved, we proposed a new strategy to explore food effect based on the absorption PBPK model. Based on the accurate prediction by absorption PBPK model, the food effect studies for qualified innovative drugs would be nested in MAD clinical trials to intend replacing the early independent food effect study. That would be promising to reduce costs and time for drug development, and also to provide the template for early food effect study in China.
ABSTRACT
OBJECTIVE: To characterize the effects of food intake on the pharmacokinetic (PK) profile of oral baicalein chewable tablets at dose of 400 mg. METHODS: In this randomized, 2-way crossover, placebo-control study, 12 healthy adult volunteers were assigned to receive a single dose of baicalein 400 mg or placebo after an overnight fast (fasted condition) or high-fat breakfast (fed condition). Concentrations of baicalein and its major metabolite baicalin in plasma were measured using HPLC-MS/MS. PK parameters were analyzed and safety was assessed. RESULTS: The pharmacokinetic parameters of baicalein in fasted and fed states were as follows: ρmax(15.752 ± 9.328) vs (19.572 ± 9.439) ng · mL-1; AUC0-t(89.468 ± 48.631) vs (122.073 ± 28.285) ng · h · mL-1; AUC0-∞(93.356 ± 50.110) vs (126.212 ± 28.270) ng · h · mL-1. The pharmacokinetic parameters of baicalin in fasted and fed states were as follows: ρmax(182.472 ± 99.555) vs (154.782 ± 10.834) ng · mL-1; AUC0-t(1 193.230 ± 693.408) vs (933.921 ± 282.318) ng · h · mL-1; AUC(0-∞) (1 266.425 ± 866.664) vs (940.882 ± 286.192) ng · h · mL-1. CONCLUSION: There suits of this study show that an increase in systemic exposure is observed for baicalein and a decrease in exposure is observed for baicalin when baicalein was taken with food. Baicalein 400 mg was generally well tolerated, with comparable adverse events in both the fed and the fasted states. The increase in exposure did not appear to impact the tolerability of the formulation.
ABSTRACT
OBJECTIVE: To investigate the bioequivalence of clopidogrel bisulfate under fasting and fed conditions and the effect of food on the pharmacokinetics of clopidogrel in chinese volunteers.
ABSTRACT
CONCLUSION: The use of nanocrystal technology for aprepitant capsules could significantly improve the solubility and dissolution rate in vitro, and then improve the rate and extent of oral absorption and reduce the influences of food effects.
ABSTRACT
The purpose of this study is to assess the nutritional value and biological effect of Collybia Velutipes. The results were as follows: (1) 10% Collybia Velutipes extract contains 19210mg/L of total amino acid. It is more than the content in the equal amount of mushrooms. (2) The kindergarten children were fed with Collybia Velutipes product for 7 weeks. It was found that the height and the circumference of the mid-upper arm in the children were significantly higher than the control. (3) Weanling male and female rats of wistar strain were divided into two groups ana led the following diets: group l(control), Collybia Velutipes (CV) free diet; group 2(subject), diet containing 25% CV product which contains 2.5% dried CV. The rats were fed the diet ad libitum for 6 weeks. At the end of the experiment, we found that the food effect (FE) of the subject group was significantly higher than the control (P