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

NCT ID: NCT01928316

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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

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Healthy

Keywords

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Healthy Bioequivalence Mizolastine Domestic Imported

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

Healthy male volunteers will receive single oral dose of 10 mg imported mizolastine tablet on Day 1 and single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 8.

Group Type EXPERIMENTAL

Mizolastine domestic (made in China)

Intervention Type DRUG

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

Mizolastine (imported)

Intervention Type DRUG

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

Sequence B

Healthy male volunteers will receive single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 1 and single oral dose of 10 mg imported mizolastine tablet on Day 8.

Group Type EXPERIMENTAL

Mizolastine domestic (made in China)

Intervention Type DRUG

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

Mizolastine (imported)

Intervention Type DRUG

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

Interventions

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Mizolastine domestic (made in China)

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

Intervention Type DRUG

Mizolastine (imported)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No history of smoking
* Body mass index between 18 and 28 kilogram per square meter
* Health status considered good by the investigator according to physical examination, medical history, vital signs, electrocardiogram and clinical laboratory results
* Must be able to read and understand the informed consent form and sign the informed consent form before carrying out any operation related to the study

* Serious alcohol abuse
* Known allergy to active ingredients or excipients
* Habitual use of any drug including Chinese medicine
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

Role: STUDY_DIRECTOR

Xian-Janssen Pharmaceutical Ltd.

Other Identifiers

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MIZOALY1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR017872

Identifier Type: -

Identifier Source: org_study_id