Status:
COMPLETED
Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
Eligibility Criteria
Inclusion
- Age \>= 20 and \<= 35 years
- Weight: Body Mass Index \>= 18.5 and \< 25
- Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
- Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
Exclusion
- History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
- History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin etc.) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
- History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
- History of bleeding tendency
- History of alcohol or drug abuse
- Participation to another trial with an investigational drug within 4 months prior to the trial
- Whole blood donation more than 400 ml within 3 months prior to the trial
- Whole blood donation more than 100 ml within 1 month prior to the trial
- Donation of constituent of blood of more than 400 ml within 1 month prior to the trial
- Any medication which might influence the results of the trial within 10 days prior to the trial
- Excessive physical activities within 7 days prior to the trial
- Alcohol drinking within 3 days prior to the trial
- History of orthostatic hypotension, fainting spells or blackouts
- Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02187575
Start Date
July 1 2002
Last Update
July 14 2014
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