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Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body

Schizophrenia Clinical Trial

Official title:
Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets (200 mg) in Chinese Healthy Subjects Under Single Dose, Randomized, Open, Two Formulation, Two Sequence, Two Cycle, Double Crossover, Fasting, and Postprandial Conditions

Clinical Trial Summary

The experiment adopts a single center, randomized, open, single dose, two cycle, and double crossover design. The subjects were randomly divided into TR and RT groups. In the first cycle, they received the test or control formulation on an empty stomach or after a meal. After a cleaning period, they entered the second cycle and received the control or test formulation in the same state. The cleaning period between the two cycles was 7 days.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06066112
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact Yu Cao
Phone 18661809090
Email caoyu1767@126.com
Status Recruiting
Phase Phase 1
Start date September 20, 2023
Completion date March 31, 2024
View Details
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