Healthy
Conditions
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
Interventions
DRUGMobic, China, 7.5 mg
DRUGMobic, Germany, 7.5 mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | Up to 96 hours after drug administration |
| Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity) | Up to 96 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Terminal rate constant in plasma (λ) | Up to 96 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | Up to 96 hours after drug administration |
| Mean residence time of the analyte (MRT) | Up to 96 hours after drug administration |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | Up to 96 hours after drug administration |
| Time to achieve Cmax (tmax) | Up to 96 hours after drug administration |
| Number of patients with clinically relevant changes from baseline in laboratory values | Baseline, up to day 5 after last drug administration |
| Number of Participants with Adverse Events | Up to day 5 after last drug administration |
| Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure) | Baseline, up to day 5 after last drug administration |
| Global assessment of tolerability by investigator on a 4-point scale | Day 5 after last drug administration |
| Apparent volume of distribution following extravascular administration (Vd/F) | Up to 96 hours after drug administration |
| Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t) | Up to 96 hours after drug administration |
Outcome results
None listed