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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Brotizolam; Drug: WE 941 OD tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02218645

263.508

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

WE 941 OD

Experimental group

Treatment:

Drug: WE 941 OD tablets

Brotizolam

Active Comparator group

Treatment:

Drug: Brotizolam