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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02218658
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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)

Condition or disease Intervention/treatment Phase
Healthy Drug: WE941 OD tablets Drug: Brotizolam Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : July 2000
Actual Primary Completion Date : August 2000

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: WE 941 OD Drug: WE941 OD tablets
Active Comparator: Brotizolam Drug: Brotizolam
Other Name: Lendormin®

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02218658    
Other Study ID Numbers: 263.507
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs