Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

This study has been completed.

First Received: January 15, 2008 Last Updated: January 31, 2008 History of Changes

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601302

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.

Condition	Intervention
Hypertension Chronic Stable Angina Vasospastic Angina	Drug: Amlodipine

MedlinePlus related topics: Angina High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fed Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Twenty-one day washout ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	April 2004
Study Completion Date:	May 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601302

Locations

United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Walter Parham, MD

Cetero Research

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	AMLO-02
Study First Received:	January 15, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00601302 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vasodilator Agents
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Calcium Channel Blockers
Pain
Cardiovascular Agents
Ischemia
Antihypertensive Agents

Amlodipine
Chest Pain
Calcium, Dietary
Signs and Symptoms
Malnutrition
Angina Pectoris, Variant
Angina, Unstable
Hypertension
Prinzmetal's Variant Angina

Additional relevant MeSH terms:

Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Calcium Channel Blockers
Pain
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Chest Pain
Amlodipine
Membrane Transport Modulators
Signs and Symptoms
Angina Pectoris, Variant
Therapeutic Uses
Cardiovascular Diseases
Angina, Unstable
Hypertension

ClinicalTrials.gov processed this record on May 06, 2009