Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

Sponsor

Roxane Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT01712100

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2007

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: irbesartan

300 mg tablet

Drug: Irbesartan

Active Comparator: Avapro

300 mg tablet

Drug: Avapro

Outcome Measures

Primary Outcome Measures

bioequivalence determined by statistical comparison Cmax [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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male and female subjects between the ages of 18 and 45 years (inclusive).
Voluntary consent to participate in the study.
Body Mass Index (BMI) between 18 and 30 (inclusive).
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).
No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

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.
A history of allergic or adverse responses to Irbesartan, or any comparable or similar product.
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.
Subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation.
Subjects must not have made a plasma donation within 14 days of study initiation.
Participation in a clinical trial within 30 days prior to study initiation.
Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study.
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.
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.
Smoking or use of tobacco products within 6 months prior to or during the study.
Female subjects who are lactating.
Positive serum pregnancy test for female subjects.
Positive blood screen for HIV, Hepatitis B or Hepatitis C.
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

Locations

	Site	City	State	Country	Postal Code
1	Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)	San Antonio	Texas	United States	78217

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator: Jolene K Berg, MD, Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roxane Laboratories

ClinicalTrials.gov Identifier:

NCT01712100

Other Study ID Numbers:

IRBE-T300-PVFD-1

First Posted:

Oct 23, 2012

Last Update Posted:

Jan 23, 2018

Last Verified:

Jan 1, 2018

Additional relevant MeSH terms:

Hypertension

Malnutrition

Irbesartan

Study Results

No Results Posted as of Jan 23, 2018