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

August 15, 2014 updated by: Boehringer Ingelheim

Clinical Pharmacological Study on Absorption From Mucous Membrane of Oral Cavity of WE 941 OD Tablets

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

10

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WE 941 OD under deglutition
Drug: WE 941 OD tablets
Experimental: WE 941 OD under non-deglutition
Drug: WE 941 OD tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: up to 17 days
up to 17 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

March 1, 2000

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

August 15, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 263.506

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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