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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02218671

Enrollment

Registered

2014-08-18

Start date

2000-03-31

Completion date

Unknown

Last updated

2014-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGWE 941 OD tablets

Study design

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Number of patients with adverse events	up to 17 days

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026