Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Mobic, China, 7.5 mg
Drug: Mobic, Germany, 7.5 mg
Details and patient eligibility
About
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
Enrollment
20 patients
Sex
Male
Ages
18 to 40 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
20 participants in 2 patient groups
Mobic Germany
Active Comparator group
Treatment:
Drug: Mobic, Germany, 7.5 mg
Drug: Mobic, China, 7.5 mg
Mobic China
Experimental group
Treatment:
Drug: Mobic, Germany, 7.5 mg
Drug: Mobic, China, 7.5 mg
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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