Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy’s Under Fasting Conditions

Overview

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

Full Title of Study: “An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets Under Fasting Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2002

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.

Interventions

  • Drug: Amlodipine
    • Amlodipine Tablets, 10 mg

Arms, Groups and Cohorts

  • Experimental: Amlodipine Tablets, 10 mg
    • Amlodipine Tablets, 10 mg of Dr. Reddy’s Laboratories Limited
  • Active Comparator: Norvasc Tablets, 10 mg

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on Cmax and AUC parameters
    • Time Frame: 3 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr. Reddy’s Laboratories Limited
  • Provider of Information About this Clinical Study
    • M.S. Mohan/Senior Manager R&D, Dr. Reddy’s Laboratories Limited
  • Overall Official(s)
    • Ralph Scallion EE, MD, Principal Investigator, AAI Clinic

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