NCT03646526

Bioavailability Study of Amitriptyline Hydrochloride Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical study is a single-center, randomized, open clinical study divided into two parts, the first part is the pre-test and the second part is the formal test. Both pre-test and formal trials were designed using two preparations, two cycles, and a self-crossover controlled trial. Twelve subjects were enrolled in the pre-test and randomly divided into two groups. Each group received 25 mg of the test preparation or reference preparation in the first day of each cycle, before the administration (0 h) and after the administration 0.5 h, 1.0 h, 2.0 h, 2.5 h, 3.0 h, 3.5 h, 4.0 h, 4.5 h, 5.0 h, 5.5 h, 6.0 h, 7.0 h, 8.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, 48.0 h, 72.0 h, 96.0 h, 120.0 h, 144 h, 168 h, and 192 h blood samples were measured for plasma amitriptyline concentration for bioequivalence analysis, and the concentration of the active metabolite nortriptyline was determined as supportive evidence of comparable efficacy. The pre-test results will provide the basis for formal testing. The cleaning period is 21 ± 1 day. The formal trials were divided into fasting and postprandial trials to evaluate the bioequivalence of the test preparation and the reference preparation in a single dose of hollow and postprandial administration in healthy Chinese subjects. Fasting and postprandial trials were enrolled in 24 subjects and randomly divided into 2 groups. Each group received 25 mg of the test preparation or reference preparation on the first day of each cycle, before the administration (0 h) and after the administration 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 5.0 h, 6.0 h, 7.0 h, 8.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, 48.0 h, 72.0 h, 96.0 h, 120.0 h and 144 h blood samples were measured for plasma concentrations of amitriptyline for bioequivalence analysis， and the concentration of the active metabolite nortriptyline was determined as supportive evidence of comparable efficacy.. The cleaning period is 21 ± 1 day. Based on the results of the first part of the pre-test evaluation, the experimental design and sampling time and other contents of the second part of the formal test may require necessary modifications. The fasting test and the postprandial test in the formal test were carried out independently.

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）	Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）is a generic product manufactured by Hunan Dongting Pharmaceutical Co., Ltd.
DRUG	Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）	Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）is a generic product manufactured by Sandoz Inc;

Timeline

• Start date: 2018-04-04
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-08-24
• Last updated: 2019-08-01

Locations

1 site across 1 country: China