Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males

The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis), Both Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)

The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.

Inclusion Criteria:

• 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 Criteria:

• 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