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 (C_max) and areas under the plasma-concentration curve (AUC) for 72 hours exposure (AUC_0–72) and total exposure (AUC_0–∞). All participants completed the whole study without side effects being observed. The C_max 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 AUC_0–72 and AUC_0–∞ 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 C_max, but no significant change in AUC values.

Author Details

Authors

• Jian-kang Li*
• Li-kun Ding*
• Xue-qin Li*
• Min-chun Chen
• Lei Wang
• Jing Yang
• Ying Song
• Wei Song
• Yan-yan Jia
• Ai-dong Wen

Departments

• Department of Pharmacy, First Affiliated Hospital of the Fourth Military Medical University, Xi’an, Shaanxi, China
  
  *These authors contributed equally to the completion of this study and the writing of this paper.

Address

Dr. Ai-dong Wen
Department of Pharmacy
First Affiliated Hospital of the Fourth Military Medical University
Changle West Street 15
Xi’an, Shaanxi 710032, China
Email: [email protected]

Citation