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

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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02218645
Enrollment
30
Registered
2014-08-18
Start date
2000-08-31
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 and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.

Interventions

DRUGWE 941 OD tablets
DRUGBrotizolam

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

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

MeasureTime 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

MeasureTime frame
tmax (time to maximum plasma concentration)up to 24 hours after drug administration
MRT (Mean residence time)up to 24 hours after drug administration
Number of patients with adverse eventsup to 30 days

Outcome results

None listed

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