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

Boehringer Ingelheim10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

WE 941 OD tabletsDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients with adverse events

Time frame: up to 17 days

Secondary Outcomes

Area under the plasma concentration-time curve from zero to 24hours (AUC0-24 )

Time frame: up to 24 hours post dose

Maximum concentration of the analyte in plasma (Cmax)

Time frame: up to 24 hours

Cmax ratio for non-deglutition to deglutition

Time frame: up to 24 hours

Data from ClinicalTrials.gov

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