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

Exclusion Criteria

• •\- Hypersensitivity to Benazepril (Lotensin®) or thiazide diuretics such as hydrochlorothiazide (Oretic® and Hydro Diuril®).
• •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.