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.

NCT03517033 Phase 1 COMPLETED

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.

Details

Lead sponsor	Torrent Pharmaceuticals Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Start date	2011-05
Completion	2011-06

Conditions

• Healthy Subjects

Interventions

• Torrent's Nebivolol Tablets
• Forest Pharmaceuticals Inc.'s Bystolic Tablets

Primary outcomes

• Cmax — pre-dose to 72 hours post-dose
• AUC — pre-dose to 72 hours post-dose