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

NCT ID: NCT02218671

Last Updated: 2014-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WE 941 OD under deglutition

Group Type EXPERIMENTAL

WE 941 OD tablets

Intervention Type DRUG

WE 941 OD under non-deglutition

Group Type EXPERIMENTAL

WE 941 OD tablets

Intervention Type DRUG

Interventions

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WE 941 OD tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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263.506

Identifier Type: -

Identifier Source: org_study_id

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