NCT03517033

Bioequivalence Study of Torrent Pharmaceuticals Ltd's Nebivolol 20 mg Tablet

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Torrent's Nebivolol Tablets
DRUG	Forest Pharmaceuticals Inc.'s Bystolic Tablets

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2018-05-07
• Last updated: 2018-05-07