Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT03517033
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Nebivolol 20 mg Tablet
Sponsor:
Torrent Pharmaceuticals Limited
Organization:
Study Overview
Official Title:
An Open Label, Randomized, 2 -Period, 2 -Treatment, 2- Sequence, Crossover, Single-Dose BE Study of Nebivolol 20 mg Tablet [Torrent, India] Vs Bystolic® 20 mg Tablet [ Forest Pharmaceuticals Inc., USA] in Healthy Subjects Fed Condition.
Status:
COMPLETED
Status Verified Date:
2018-04
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:
Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.
Detailed Description:
An Open Label, Randomized, 2- Period, 2 -Treatment, 2 -Sequence, Crossover, Single- dose Bioequivalence study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Ltd., USA) in Healthy Volunteers Under Fed Condition.
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?: