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A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions

NCT00870571 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-08-16

No results posted yet for this study

Summary

The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose

A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions

DRUG

NorvasC® 10 mg Tablets

B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fed conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Gaetano Morelli,, MD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • Canada

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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 NCT00870571 on ClinicalTrials.gov