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Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan Tablets Under Fed Conditions

NCT01712100•Roxane Laboratories

Summary

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

Eligibility

Age

18 - 45 years

Sex

ALL

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.
+4 more criteria

Locations (1)

Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)

San Antonio, Texas, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

August 1, 2007

Completion Date

August 1, 2007

Last Updated

January 23, 2018

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

Irbesartan

DRUG

Avapro

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

Inclusion Criteria

Exclusion Criteria

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