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.

NCT03517020 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	22
Start date	2011-04
Completion	2011-06

Conditions

• Healthy Subjects

Interventions

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

Primary outcomes

• Cmax — pre-dose to 8 hours post-dose
• AUC — pre-dose to 8 hours fasting post-dose