Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-01 @ 10:51 AM
Study NCT ID:
NCT00840632
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2009-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trandolapril 4 mg Tablet Under Fasting Conditions
Sponsor:
Teva Pharmaceuticals USA
Organization:
Study Overview
Official Title:
A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Trandolapril 4 mg Tablets Versus Mavik® 4 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2024-08
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 objective of this study is to compare the rate and extent of absorption of trandolapril from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets under fasting conditions.
Detailed Description:
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Statistical Methods: FDA bioequivalence statistical methods
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: