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
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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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2001-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Mobic Germany
Mobic, China, 7.5 mg
Mobic, Germany, 7.5 mg
Mobic China
Mobic, China, 7.5 mg
Mobic, Germany, 7.5 mg
Interventions
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Mobic, China, 7.5 mg
Mobic, Germany, 7.5 mg
Eligibility Criteria
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Inclusion Criteria
* Written informed consent in accordance with Good Clinical Practice (GCP)
* Age \>= 18 and \<= 40 years
* Broca \> - 20% and \< + 20%
Exclusion Criteria
* 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
18 Years
40 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Other Identifiers
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107.234
Identifier Type: -
Identifier Source: org_study_id
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