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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02218658

Enrollment

Registered

2014-08-18

Start date

2000-07-31

Completion date

Unknown

Last updated

2014-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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)

Interventions

DRUGWE941 OD tablets

DRUGBrotizolam

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 35 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026