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Bioavailability Study of Amitriptyline Hydrochloride Tablets

NCT03646526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-01

No results posted yet for this study

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.

Conditions

  • Depressive Disorder

Interventions

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;

Sponsors & Collaborators

  • Hunan DongtingPharm.Co.Ltd

    collaborator UNKNOWN

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jian LIU, Master · The First Affiliated Hospital,ZheJiang Univercity

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646526 on ClinicalTrials.gov