Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-28 @ 12:02 PM
Study NCT ID:
NCT04964050
Status:
WITHDRAWN
Last Update Posted:
2023-01-27
First Post:
2021-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study Between Capozide Versus ACE-Hemmer-ratiopharm in Healthy Adult Participants Under Fasting Conditions
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
An Open-label, Randomized Three Period, Three Sequence, Partially Replicated Crossover Bioequivalence Study of Two Oral Formulations of Captopril/Hydrochlorothiazide 50/25 mg Tablets in Healthy Adult Participants Under Fasting Conditions
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Internal sponsor decision to terminate project prematurely based on a waiver granted by Egypt EDA (Egyptian drug authority). No subjects were enrolled.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a bioequivalence study to compare Capozide (test product \[T\]) to ACE-Hemmer-ratiopharm (reference product\[R\]) produced by Ratiopharm GmbH Germany in healthy adult participants under fasting conditions.
ACE-Hemmer-ratiopharm®is the registered trademark of Ratiopharm GmbH Germany.
ACE-Hemmer-ratiopharm®is the registered trademark of Ratiopharm GmbH Germany.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: