Bioavailability Study of Amitriptyline Hydrochloride Tablets

Summary

Main Objectives: In Chinese healthy subjects under both fasting and postprandial conditions, amitriptyline hydrochloride tablets (size: 25 mg) produced by Sandoz Inc., US Orange Book, were used as reference preparations. A single-dose oral reference preparation and amitriptyline hydrochloride tablets (size: 25 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd., and the calculation of the drug by the time course of amitriptyline and its active metabolite, nortriptyline, in vivo The kinetic parameters were compared, and the relative bioavailability of the two was compared to evaluate bioequivalence, which provided the basis for the bioequivalence study of amitriptyline hydrochloride tablets by Hunan Dongting Pharmaceutical Co., Ltd. Secondary Objective: To monitor the safety of fasting and postprandial oral test and reference preparations.

Timeline

Start

2018-04-04

Primary completion

2019-01-31

Completion

2019-01-31

Publications

• Zhai Y, Wu L, Zheng Y, Wu M, Huang Y, Huang Q, Shentu J, Zhao Q, Liu J. Bioequivalence Study of Amitriptyline Hydrochloride Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2020 Aug 4;14:3131-3142. doi: 10.2147/DDDT.S258173. eCollection 2020.

Drugs

Indications