NCT01928316

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

Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a single-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study. Approximately, 24 healthy volunteers will be enrolled in the study. Eligible volunteers will be randomly allocated to either Sequence A group or Sequence B group. On Day 1, volunteers from Sequence A group will receive imported mizolastine tablets and volunteers from Sequence B group will receive domestic mizolastine tablets. There will be a washout period (no treatment) of 7 Days. On Day 8, the two sequence groups will be switched. Volunteers from Sequence A group will receive domestic mizolastine and volunteers from Sequence B group will receive imported mizolastine tablets. Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be measured throughout the study. The maximum study duration for each volunteer will be approximately 16 days.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2013-08-23
• Last updated: 2013-08-23