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

NCT01190748 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-22

No results posted yet for this study

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 fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Galantamine 4 mg Tablet, single dose

A: Experimental Subjects received Purepac Pharmaceutical, Company, U.S.A. formulated products under fasting conditions

DRUG

Reminyl 4 mg Tablet, single dose

B: Active comparator Subjects received Janssen Pharmaceutica Products,U.S.A., formulated products under fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Benoit Girard, M.D. · SFBC Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190748 on ClinicalTrials.gov