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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: WE941 OD tablets
* Drug: Brotizolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WE 941 OD<br> | Drug: WE941 OD tablets<br> <br> |
| Active Comparator: Brotizolam<br> | Drug: Brotizolam<br> <br> * Other names: Lendormin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |