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NCT00601302 Clinical Trial

Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

Hypertension Clinical Trial

Official title:
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00601302
Other study ID # AMLO-02
Secondary ID
Status Completed
Phase N/A
First received January 15, 2008
Last updated January 19, 2018
Start date April 2004
Est. completion date May 2004

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2004
Est. primary completion date April 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

- Positive test for HIV, Hepatitis B, or Hepatitis C.

- Treatment with known enzyme altering drugs.

- History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine

Locations
Country Name City State
United States Gateway Medical Research, Inc. Saint Charles Missouri

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence Baseline, Two period, Twenty-one day washout
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