Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

NCT ID: NCT01712100

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2007-08-31

Brief Summary

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

irbesartan

300 mg tablet

Group Type: EXPERIMENTAL

Irbesartan

Intervention Type: DRUG

Avapro

300 mg tablet

Group Type: ACTIVE_COMPARATOR

Avapro

Intervention Type: DRUG

Interventions

Irbesartan

Intervention Type: DRUG

Avapro

Intervention Type: DRUG

Eligibility 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, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roxane Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolene K Berg, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

San Antonio, Texas, United States

Countries

United States

Other Identifiers

IRBE-T300-PVFD-1

Identifier Type: -

Identifier Source: org_study_id