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Completed

NCT Number: NCT02218671

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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

WE 941 OD tablets

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: up to 17 days

Secondary outcomes

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

    Time frame: up to 24 hours post dose

  2. Maximum concentration of the analyte in plasma (Cmax)

    Time frame: up to 24 hours

  3. Cmax ratio for non-deglutition to deglutition

    Time frame: up to 24 hours

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2000
First posted
Aug 18, 2014
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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