Overview

Bioequivalence Study of Benazepril HCl / Hydrochlorothiazide 20 mg/ 25 mg Tablets Under Fasting Conditions

Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to determine the bioavailability of benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy fasted subjects. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ranbaxy Laboratories Limited
Treatments:
Benazepril
Hydrochlorothiazide
Criteria
Inclusion Criteria:

- Healthy Subjects at least 18 years of age.

- 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 weighing at least 110 pounds.

Exclusion Criteria:

- - Hypersensitivity to benazepril (Lotensin®) or thiazide diuretics such as
hydrochlorothiazide (Oretic®).

- Any history of clinical condition that might affect drug absorption, metabolism or
excretion.

- Recent history (within one year) 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 past 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 smoking of more than 5 cigarettes daily use of nicotine-containing products
beginning 3 months before study medication administration through the final
evaluation.

- If female, the subject is lactating or has a positive pregnancy test at screening and
prior to each of the treatment periods. Females of child bearing potential 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 implant, condom with spermacide, diaphragm with
spermicide, IUD, vaginal spermicide Suppository, surgical sterilization of their
partner(s) or abstinence. Females taking oral contraceptives must have taken them
consistently for at least three months prior to receiving study medication.

- Alcohol, grapefruit beverages or foods or caffeine beverages or foods beginning 1 day
before each study medication administration through each study confinement period.
Such restricted items include coffee, tea, iced tea, coke®, Pepsi®, Mountain Dew®,
Chocolate, brownies, etc.