NCT03517020

Bioequivalence Study of Torrent Pharmaceuticals's 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]Versus Bystolic® 20 mg Tablet [ Forest Pharmaceuticals Inc., USA] in Healthy Subjects - Fasted.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (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 Pharmaceutical Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fasting Condition.

Conditions

• Healthy Subjects

Interventions

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

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2018-05-07
• Last updated: 2018-05-07