Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions

Condition(s) targeted: Hypertension

Intervention: Irbesartan and Hydrochlorothiazide (Drug); Avalide (Drug)

Phase: N/A

Status: Completed

Sponsored by: Roxane Laboratories

Official(s) and/or principal investigator(s):
Jolene K Berg, MD, Principal Investigator, Affiliation: Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.

Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan / Hydrochlorothiazide 300/25 mg Tablets Under Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: bioequivalence determined by statistical comparison Cmax

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male and female subjects between the ages of 18 and 45 years (inclusive). 2. Voluntary consent to participate in the study. 3. Body Mass Index (BMI) between 18 and 30 (inclusive). 4. Female subjects of childbearing potential — not surgically sterile or at least 2 years postmenopausal — must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum). 5. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. 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.

Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research), San Antonio, Texas 78217, United States

Starting date: September 2007
Last updated: October 19, 2012