NCT02218671

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
14.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

Same day

First QC Date

August 15, 2014

Last Update Submit

August 15, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    up to 17 days

Secondary Outcomes (3)

  • 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

Study Arms (2)

WE 941 OD under deglutition

EXPERIMENTAL
Drug: WE 941 OD tablets

WE 941 OD under non-deglutition

EXPERIMENTAL
Drug: WE 941 OD tablets

Interventions

WE 941 OD tabletsDRUG
WE 941 OD under deglutitionWE 941 OD under non-deglutition

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 18, 2014

Study Start

March 1, 2000

Primary Completion

March 1, 2000

Last Updated

August 18, 2014

Record last verified: 2014-08