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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01131936
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Amlodipine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2002
Study Completion Date: November 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.,

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131936

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

No publications provided

Responsible Party: M.S. Mohan/Senior Manager R&D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01131936     History of Changes
Other Study ID Numbers: AAI-US-133
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013