Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT02218658
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2014-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: