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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01131936
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : June 14, 2010
Information provided by:
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Amlodipine Phase 1

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets Under Fed Conditions
Study Start Date : August 2002
Actual Primary Completion Date : September 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

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 Name: Norvasc 10 mg tablets of Pfizer, Inc.,
Active Comparator: Norvasc Tablets, 10 mg Drug: Amlodipine
Amlodipine Tablets, 10 mg
Other Name: Norvasc 10 mg tablets of Pfizer, Inc.,

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01131936

United States, North Carolina
AAI Clinic
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: Ralph Scallion EE, MD AAI Clinic

Responsible Party: M.S. Mohan/Senior Manager R&D, Dr. Reddy's Laboratories Limited Identifier: NCT01131936     History of Changes
Other Study ID Numbers: AAI-US-133
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: June 14, 2010
Last Verified: June 2010

Keywords provided by Dr. Reddy's Laboratories Limited:
Amlodipine Besylate

Additional relevant MeSH terms:
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents