NCT01190761

Bioequivalence Study of Galantamine 4 mg Tablet and Reminyl Following a 4 mg Dose in Healthy Subjects Under Fed Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Galantamine 4 mg Tablet and Reminyl Following a 4 mg Dose in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the rate and extent of absorption of Purepac, a subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P., U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fed conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design. Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Galantamine 4 mg Tablet and Reminyl Following a 4 mg Dose in Healthy Subjects Under Fed Conditions. Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Galantamine 4 mg Tablet, single dose	A: Experimental Subjects received Purepac Pharmaceutical, Company, U.S.A. formulated products under fed conditions
DRUG	Reminyl 4 mg Tablet, single dose	B: Active comparator Subjects received Janssen Pharmaceutica Products,U.S.A., formulated products under fed conditions

Timeline

• Start date: 2004-12-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2010-08-30
• Last updated: 2010-08-30

Locations

1 site across 1 country: Canada