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Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irbesartan
Avapro
Sponsored by
Roxane Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

irbesartan

Avapro

Arm Description

300 mg tablet

300 mg tablet

Outcomes

Primary Outcome Measures

bioequivalence determined by statistical comparison Cmax

Secondary Outcome Measures

Full Information

First Posted
October 19, 2012
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01712100
Brief Title
Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan Tablets Under Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxane Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
irbesartan
Arm Type
Experimental
Arm Description
300 mg tablet
Arm Title
Avapro
Arm Type
Active Comparator
Arm Description
300 mg tablet
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Intervention Type
Drug
Intervention Name(s)
Avapro
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolene K Berg, MD
Organizational Affiliation
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States

12. IPD Sharing Statement

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Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

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