Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males

August 15, 2014 updated by: Boehringer Ingelheim

The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) Taken Without Water and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis) Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)

The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 20 and 35 years
  • Weight between 50 and 80 kg
  • Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
  • Judged as eligible as a study object following the screening test by the investigator
  • Volunteers to participate in the study, who are capable of giving written informed consent

Exclusion Criteria:

  • Known hypersensitivity to drugs
  • History of drug or alcohol abuse
  • Received other investigational drug within 4 months of the trial drug administration
  • Had > 400 mL of whole blood drawn within 3 months of the trial drug administration
  • Had > 400 mL of blood components drawn within 1 month of the trial drug administration
  • Used any drug within 10 days of the trial drug administration
  • Engaged in strenuous exercise within 5 days of the trial drug administration
  • Consumed alcohol within 3 days of the trial drug administration
  • Judged as ineligible for the study participation by the investigator for a reason other than above

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
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WE 941 OD
Drug: WE941 OD tablets
Active Comparator: Brotizolam
Drug: Brotizolam
Other Names:
  • Lendormin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
Cmax (maximum plasma concentration)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: up to 30 days
up to 30 days
tmax (time to maximum plasma concentration)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
MRT (Mean residence time)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration

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

July 1, 2000

Primary Completion (Actual)

August 1, 2000

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

  • 263.507

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.

Clinical Trials on Healthy

Clinical Trials on Brotizolam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe