Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

Roxane Laboratories40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Chronic Stable Angina Vasospastic Angina

Interventions

AmlodipineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, Twenty-one day washout

Data from ClinicalTrials.gov

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