Pharmacological Study on Absorption of WE 941 OD Tablets in Japanese Healthy Male Volunteers

Phase 1

Completed

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

• Registration Number: NCT02218671
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE 941 OD tablets are administered in Japanese healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2000-03
• 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: 10

Inclusion Criteria

• Healthy male volunteers
• age 20 - 35 years
• body weight 50 - 80 kg
• Body Mass Index (BMI) +/- 20%

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WE 941 OD under deglutition	WE 941 OD tablets	-
WE 941 OD under non-deglutition	WE 941 OD tablets	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 17 days

Secondary Outcome Measures

Name	Time	Method
Maximum concentration of the analyte in plasma (Cmax)	up to 24 hours
Cmax ratio for non-deglutition to deglutition	up to 24 hours
Area under the plasma concentration-time curve from zero to 24hours (AUC0-24 )	up to 24 hours post dose