Pharmacological Study on Absorption of WE 941 OD Tablets... | NCT02218671

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

NCT02218671

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Aug 18, 2014Estimated

Enrollment

Phase

Phase 1

Conditions

Healthy

Interventions

WE 941 OD tablets

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2000

Primary Completion Date

Mar 2000Actual

Completion Date

Not provided

First Submitted Date

Aug 15, 2014

First Submission Date that Met QC Criteria

Aug 15, 2014

First Posted Date

Aug 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2014

Last Update Posted Date

Aug 18, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WE 941 OD under deglutition	Experimental		Drug: WE 941 OD tablets
WE 941 OD under non-deglutition	Experimental		Drug: WE 941 OD tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WE 941 OD tablets	Drug		WE 941 OD under deglutition WE 941 OD under non-deglutition

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided