Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fasted Conditions

This study has been completed.
Information provided by (Responsible Party):
Roxane Laboratories Identifier:
First received: October 19, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan 300 mg Tablets under fasted conditions

Condition Intervention
Drug: Irbesartan
Drug: Avapro

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan Tablets Under Fasting Conditions

Resource links provided by NLM:

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: Blood samples will be collected in Vacutainers containing K3EDTA (1 x 7 mL) before dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: irbesartan
300 mg tablet
Drug: Irbesartan
Active Comparator: Avapro
300 mg tablet
Drug: Avapro


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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, 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01712113

United States, Texas
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Jolene K Berg, MD Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
  More Information

Responsible Party: Roxane Laboratories Identifier: NCT01712113     History of Changes
Other Study ID Numbers: IRBE-T300-PVFS-1 
Study First Received: October 19, 2012
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2016