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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: WE941 OD tablets

Drug: Brotizolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT02218658

263.507

Details and patient eligibility

About

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 healthy adult male subjects (open-labelled, 2-way cross-over study)

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