Status:
COMPLETED
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in heal...
Eligibility Criteria
Inclusion
- Age between 20 and 35 years
- Weight between 50 and 80 kg
- Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
- Judged as eligible as a study object following the screening test by the investigator
- Volunteers to participate in the study, who are capable of giving written informed consent
Exclusion
- Known hypersensitivity to drugs
- History of drug or alcohol abuse
- Received other investigational drug within 4 months of the trial drug administration
- Had \> 400 mL of whole blood drawn within 3 months of the trial drug administration
- Had \> 400 mL of blood components drawn within 1 month of the trial drug administration
- Used any drug within 10 days of the trial drug administration
- Engaged in strenuous exercise within 5 days of the trial drug administration
- Consumed alcohol within 3 days of the trial drug administration
- Judged as ineligible for the study participation by the investigator for a reason other than above
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02218658
Start Date
July 1 2000
Last Update
August 18 2014
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