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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: WE 941 OD tablets; Drug: Brotizolam

• Registration Number: NCT02218645
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2000-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2014-08-15
• Last Update Submitted: 2014-08-15
• Study First Posted: 2014-08-18
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WE 941 OD	WE 941 OD tablets	-
Brotizolam	Brotizolam	-

Primary Outcome Measures

Name	Time	Method
Cmax (maximum plasma concentration)	up to 24 hours after drug administration
AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)	up to 24 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
tmax (time to maximum plasma concentration)	up to 24 hours after drug administration
MRT (Mean residence time)	up to 24 hours after drug administration
Number of patients with adverse events	up to 30 days