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

NCT02218658 | Completed Phase 1

• 1 other identifier: 263.507
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)

  up to 24 hours after drug administration

• Cmax (maximum plasma concentration)

  up to 24 hours after drug administration

Secondary Outcomes (3)

• Number of patients with adverse events

  up to 30 days

• tmax (time to maximum plasma concentration)

  up to 24 hours after drug administration

• MRT (Mean residence time)

  up to 24 hours after drug administration

Study Arms (2)

WE 941 OD

EXPERIMENTAL

Drug: WE941 OD tablets

Brotizolam

ACTIVE COMPARATOR

Drug: Brotizolam

Interventions

WE941 OD tablets DRUG

WE 941 OD

Brotizolam DRUG

Also known as: Lendormin®

Brotizolam

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

brotizolam

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• 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: July 1, 2000
• Primary Completion: August 1, 2000
• Last Updated: August 18, 2014

Record last verified: 2014-08