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

NCT01131936 | Completed Phase 1 DMC

• 1 other identifier: AAI-US-133
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioequivalence; Amlodipine Besylate

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  4 months

Study Arms (2)

Amlodipine Tablets, 10 mg

EXPERIMENTAL

Amlodipine Tablets, 10 mg of Dr. Reddy's Laboratories Limited

Drug: Amlodipine

Norvasc Tablets, 10 mg

ACTIVE COMPARATOR

Drug: Amlodipine

Interventions

Amlodipine DRUG

Amlodipine Tablets, 10 mg

Also known as: Norvasc 10 mg tablets of Pfizer, Inc.,

Amlodipine Tablets, 10 mg; Norvasc Tablets, 10 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

AAI Clinic

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ralph Scallion EE, MD

  AAI Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: August 1, 2002
• Primary Completion: September 1, 2002
• Study Completion: November 1, 2002
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

US (1)