Status:
COMPLETED
Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the do...
Eligibility Criteria
Inclusion
- Healthy subjects as determined by results of screening
- Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age \>= 18 and \<= 50 years
- Broca \>= -20% and \<= + 20 %
Exclusion
- Any finding of the medical examination (including laboratory blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- 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 meloxicam and/or non-steroidal antirheumatic agents
- Intake of drugs with a long half-life (\>24 hours) (\<= 1 month prior to administration or during the trial)
- Use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
- Smoker (\>= 10 cigarettes or \>= 3 cigars or \>= 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse
- Drug abuse
- Blood donation (\<= 1 months prior to administration)
- Excessive physical activities (\<= 5 days prior to administration)
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
- Inability to maintain this adequate contraception during the whole study period
- Lactating
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02276352
Start Date
June 1 1999
Last Update
October 28 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.