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

May 26, 2010
May 27, 2010
June 14, 2010
August 2002
September 2002   (Final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT01131936 on Archive Site
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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.
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.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Amlodipine
Amlodipine Tablets, 10 mg
Other Name: Norvasc 10 mg tablets of Pfizer, Inc.,
  • Experimental: Amlodipine Tablets, 10 mg
    Amlodipine Tablets, 10 mg of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Amlodipine
  • Active Comparator: Norvasc Tablets, 10 mg
    Intervention: Drug: Amlodipine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2002
September 2002   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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M.S. Mohan/Senior Manager R&D, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
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Principal Investigator: Ralph Scallion EE, MD AAI Clinic
Dr. Reddy's Laboratories Limited
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP