Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02260050
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Bioequivalence of 20 mg of the New Formulation of WAL 801 CL Dry Syrup Compared to 20 mg of the Conventional Formulation of WAL 801 CL Dry Syrup Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, 2x2 Crossover Study)
Status:
COMPLETED
Status Verified Date:
2014-10
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:
To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup
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?: