Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions

An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets Under Fed Conditions

The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Amlodipine

Detailed Description

This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy volunteers with a washout period of 14 days.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • AAI Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects between 18 and 45 years of age inclusive.
• Informed of the nature of the study and given written informed consent.
• Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weigh at least 115 (Appendix I and Appendix II).

Exclusion Criteria:

• If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the three treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of themselves or their partners or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
• Hypersensitivity to amlodipine besylate (Norvasc®)or related calcium channel blockers).
• Any history of a clinical condition that might affect drug absorption, metabolism or excretion.
• Recent history of mental illness, drug addiction, drug abuse or alcoholism.
• Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
• Received an investigational drug within the 4 weeks prior to study dosing.
• Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or -herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
• Regular tobacco use in the 6 months prior to study dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlodipine Tablets, 10 mg; Amlodipine Tablets, 10 mg of Dr. Reddy's Laboratories Limited	Drug: Amlodipine; Amlodipine Tablets, 10 mg; Other Names: Norvasc 10 mg tablets of Pfizer, Inc.,
Active Comparator: Norvasc Tablets, 10 mg	Drug: Amlodipine; Amlodipine Tablets, 10 mg; Other Names: Norvasc 10 mg tablets of Pfizer, Inc.,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC parameters	4 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Ralph Scallion EE, MD, AAI Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): September 1, 2002
• Study Completion (Actual): November 1, 2002

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): June 14, 2010
• Last Update Submitted That Met QC Criteria: June 11, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Amlodipine Besylate
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: AAI-US-133