title: Effect of food on the single-dose pharmacokinetics and tolerability of clinofibrate tablets in Chinese healthy volunteers.
abstract: The aim of this study is to investigate a food effect on the single-dose pharmacokinetics and tolerability of clinofibrate tablets in 12 Chinese healthy volunteers. The authors evaluated the effect of being under a fasting or fed state at the time of drug intake on the single-dose of clinofibrate 400 mg tablets in a randomized, balanced, single-dose, two-treatment (fed and fasting), two-period, two-sequence study design with a 7-day washout period. The end points were the maximum plasma drug concentration (Cmax) and areas under the plasma-concentration curve (AUC) for 72 hours exposure (AUC0-72) and total exposure (AUC0-∞). All participants completed the whole study without side effects being observed. The Cmax mean of clinofibrate glucuronides and parent clinofibrate were 21.91, 17.85 μ/ml for the fasting state and 13.14, 11.25 μ/ml for the fed state, respectively. The AUC0-72 and AUC0-∞ of clinofibrate glucuronides and parent clinofibrate were 381.60, 307.07 μ/ ml and 404.55, 342.24 μ/ml for the fasting state and 379.02, 321.14 μ/ml and 432.24, 351.80 μ/ml for the fed state. The authors showed that food intake was associated with a significant decrease in Cmax, but no significant change in AUC values.
authors.affiliation: Department of Pharmacy, First Affiliated Hospital of the Fourth Military Medical University, Xi'an, Shaanxi, China.
authors.forename: Jian-kang
authors.initials: JK
authors.lastname: Li
authors.forename: Li-kun
authors.initials: LK
authors.lastname: Ding
authors.forename: Xue-qin
authors.initials: XQ
authors.lastname: Li
authors.forename: Min-chun
authors.initials: MC
authors.lastname: Chen
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.forename: Jing
authors.initials: J
authors.lastname: Yang
authors.forename: Ying
authors.initials: Y
authors.lastname: Song
authors.forename: Wei
authors.initials: W
authors.lastname: Song
authors.forename: Yan-yan
authors.initials: YY
authors.lastname: Jia
authors.forename: Ai-dong
authors.initials: AD
authors.lastname: Wen
mesh_terms: D000328:Adult; D019540:Area Under Curve; D018592:Cross-Over Studies; D005260:Female; D018565:Food-Drug Interactions; D006801:Humans; D008297:Male; D010642:Phenoxyacetates / Q000009:adverse effects / Q000493:pharmacokinetics*; D013607:Tablets
chemical_list: D010642:Phenoxyacetates; D013607:Tablets; C006231:clinofibrate