Overview

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

Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Amlodipine
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 (NorvascĀ®) 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.