Bioavailability Study of Amitriptyline Hydrochloride Tablets
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）; Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）
Intervention type(s): Drug; Drug
Intervention description(s): Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）is a generic product manufactured by Hunan Dongting Pharmaceutical Co., Ltd.; Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）is a generic product manufactured by Sandoz Inc;
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Amitriptyline hydrochloride