Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 7:55 AM
Study NCT ID:
NCT00985660
Status:
COMPLETED
Last Update Posted:
2009-09-28
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
Single-Dose Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets (30 mg; Mylan) and Sular® Extended Release Tablets (30 mg; First Horizon) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2009-09
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 nisoldipine extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 30 mg tablet (manufactured for First Horizon) following a single, oral 30 mg (1 × 30 mg tablet) dose administration in healthy adult subjects 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?: