NCT01146041

Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Rivastigmine 1.5 mg Capsules and Exelon Administered as 1 x 1.5 mg Capsule in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this bioequivalence study is to compare the test of Rivastigmine 1.5 mg Capsules of Dr.Reddy's Laboratories Limited with reference to Exelon 1.5 mg of Novartis in Healthy Subjects Under Fed Conditions.

Detailed description

Bioequivalence study of Rivastigmine Capsules 1.5 mg and Exelon 1.5 mg This was a single center, single-dose, open-label, randomized, 2-way crossover bioequivalence study,performed under fed conditions. The treatment phases were separated by a washout period of 7 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rivastigmine	Rivastigmine 1.5 mg Capsules

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-02-01
• Completion: 2004-04-01
• First posted: 2010-06-17
• Last updated: 2010-06-17