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

NCT06066112 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.

Randomly assign to TR or RT sequence groups based on a predetermined random table and receive the corresponding study drug according to the corresponding administration sequence.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2023-10-07
Completion
2024-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06066112 on ClinicalTrials.gov