Bioavailability Study of Amitriptyline Hydrochloride Tablets
Status:
Completed
Trial end date:
2019-01-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborator:
Hunan DongtingPharm.Co.Ltd
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination