Expired Study
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St. Charles, Missouri 63301


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00601302


Primary Contact:

Principal Investigator
Walter Parham, MD
Cetero Research


Backup Contact:

N/A


Location Contact:

St. Charles, Missouri 63301
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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