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Completed

NCT Number: NCT02218658

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

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)

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Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WE941 OD tablets

Drug

Brotizolam

Drug

Other names: Lendormin®

Primary outcomes

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

    Time frame: up to 24 hours after drug administration

  2. Cmax (maximum plasma concentration)

    Time frame: up to 24 hours after drug administration

Secondary outcomes

  1. Number of patients with adverse events

    Time frame: up to 30 days

  2. tmax (time to maximum plasma concentration)

    Time frame: up to 24 hours after drug administration

  3. MRT (Mean residence time)

    Time frame: up to 24 hours after drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2000
Primary completion
2000
First posted
Aug 18, 2014
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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