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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rivastigmine

• Registration Number: NCT01146041
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief 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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-02
• Study Completion: 2004-04
• Study First Submitted: 2010-02-10
• Status Verified: 2010-06
• Study First Submitted QC: 2010-06-16
• Last Update Submitted: 2010-06-16
• Study First Posted: 2010-06-17
• Last Update Posted: 2010-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rivastigmine	Rivastigmine	Rivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited
exelon	Rivastigmine	Exelon 1.5 mg capsules of Novartis

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC parameters	3 months