Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT00649805
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2008-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fasting Applesauce Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
Single-Dose Fasting Bioequivalence Study of Verapamil HCl Extended-Release Capsules (300 mg;Mylan) and Verelan® PM Extended-Release Capsules (300 mg; Schwarz) Sprinkled on Applesauce in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-04
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 was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following by a single, oral 300 mg (1 x 300 mg) dose administration sprinkled on one tablespoon of applesauce under fasting conditions.
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?: