Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers

NCT ID: NCT02183142

Last Updated: 2014-07-08

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Brief Summary

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The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany

Detailed Description

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Conditions

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Healthy

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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Mobic Germany

Group Type ACTIVE_COMPARATOR

Mobic, China, 7.5 mg

Intervention Type DRUG

Mobic, Germany, 7.5 mg

Intervention Type DRUG

Mobic China

Group Type EXPERIMENTAL

Mobic, China, 7.5 mg

Intervention Type DRUG

Mobic, Germany, 7.5 mg

Intervention Type DRUG

Interventions

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Mobic, China, 7.5 mg

Intervention Type DRUG

Mobic, Germany, 7.5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chinese healthy male volunteers as determined by result of screening
* Written informed consent in accordance with Good Clinical Practice (GCP)
* Age \>= 18 and \<= 40 years
* Broca \> - 20% and \< + 20%

Exclusion Criteria

* Any finding of the medical examination (blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* Hypersensitivity to Mobic and/or non-steroidal anti-inflammatory drugs
* Intake any drugs within 1 month before randomization
* Participation in another trial with an investigational drug within the last 2 month or during the trial
* Smokers ( \>= 10 cigarettes or \>= 3 cigars or \>= 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol or drug abuse
* Blood donation within the last 1 month
* Excessive physical activities within the last 5 days
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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107.234

Identifier Type: -

Identifier Source: org_study_id

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