Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712100
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

Brief Summary:
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan 300 mg Tablets under fed conditions.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan Drug: Avapro Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan Tablets Under Fed Conditions
Study Start Date : August 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Irbesartan

Arm Intervention/treatment
Experimental: irbesartan
300 mg tablet
Drug: Irbesartan
Active Comparator: Avapro
300 mg tablet
Drug: Avapro

Primary Outcome Measures :
  1. 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. ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712100

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)

Responsible Party: Roxane Laboratories Identifier: NCT01712100     History of Changes
Other Study ID Numbers: IRBE-T300-PVFD-1
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action