Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water 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.
 
ClinicalTrials.gov Identifier: NCT02218645
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: WE 941 OD tablets Drug: Brotizolam Phase 1

Layout table for study information
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) and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis), Both Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)
Study Start Date : August 2000
Actual Primary Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: WE 941 OD Drug: WE 941 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02218645    
Other Study ID Numbers: 263.508
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Brotizolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs