Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions

Exclusion Criteria

• •1. A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• •2. A history of allergic or adverse responses to irbesartan and hydrochlorothiazide, or any comparable or similar product.
• •3. Subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation.
• •4. Subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation.
• •5. Subjects must not have made a plasma donation within 14 days of study initiation.
• •6. Participation in a clinical trial within 30 days prior to study initiation.
• •7. Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study.
• •8. Use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy.
• •9. Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, MAOI, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study.
• •10. Smoking or use of tobacco products within 6 months prior to or during the study.
• •11. Female subjects who are lactating.
• •12. Positive serum pregnancy test for female subjects.
• •13. Positive blood screen for HIV, Hepatitis B or Hepatitis C.
• •14. Positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.