CompletedNot Applicable

Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

United States40 participantsStarted 2004-04

Plain-language 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 fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Bioequivalence

Timeframe: Baseline, Two period, Twenty-one day washout

Trial details

NCT IDNCT00602017

SponsorRoxane Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-05

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