Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-03 @ 4:49 AM
Study NCT ID:
NCT00649168
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2008-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
Study of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg Bromocriptine Mesylate Capsules Following a 10 mg Dose in Healthy Adult Volunteers Under Fed Conditions
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 assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine mesylate capsules, following the administration of a 10 mg dose, under fed 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?: