Clinical trial NCT02183142: Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers
Official title: Relative Bioavailability of 7.5 mg Mobic Tablet Manufactured in China in Comparison With 7.5 mg Tablets Manufactured in Germany After a Single Oral Dose in Chinese Healthy Volunteers, Open, Randomized, Two Way Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to 96 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)
timeFrame: Up to 96 hours after drug administration
Secondary outcomes:
measure: Time to achieve Cmax (tmax)
timeFrame: Up to 96 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)
timeFrame: Up to 96 hours after drug administration
measure: Terminal rate constant in plasma (λ)
timeFrame: Up to 96 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
timeFrame: Up to 96 hours after drug administration
measure: Mean residence time of the analyte (MRT)
timeFrame: Up to 96 hours after drug administration
measure: Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
timeFrame: Up to 96 hours after drug administration
measure: Apparent volume of distribution following extravascular administration (Vd/F)
timeFrame: Up to 96 hours after drug administration
measure: Number of patients with clinically relevant changes from baseline in laboratory values
timeFrame: Baseline, up to day 5 after last drug administration
measure: Number of Participants with Adverse Events
timeFrame: Up to day 5 after last drug administration
measure: Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure)
timeFrame: Baseline, up to day 5 after last drug administration
measure: Global assessment of tolerability by investigator on a 4-point scale
timeFrame: Day 5 after last drug administration
Other outcomes:
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