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A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers

NCT01928316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-08-23

No results posted yet for this study

Summary

The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers

Conditions

  • Healthy

Interventions

DRUG

Mizolastine domestic (made in China)

Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8

DRUG

Mizolastine (imported)

Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial · Xian-Janssen Pharmaceutical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-06-30
Completion
2009-06-30

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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 NCT01928316 on ClinicalTrials.gov