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
Outcome
Met primary endpoint
paper The GMRs of Cmax, AUC0-t, and AUC0-∞ between the two products, and corresponding 90% CIs, were all within the range of 80% to 125% PMID 32801649 ↗
paper This study demonstrated that the generic and reference products were well tolerated by the subjects and bioequivalent PMID 32801649 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amitriptyline | Small molecule | 25 mg | Oral |