Depressive Disorder Clinical Trial
Official title:
Bioavailability Study of Amitriptyline Hydrochloride Tablets
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.
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.
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