Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions

NCT01712126 | Completed

• 1 other identifier: IRHY-T300-PVFD-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Irbesartan and Hydrochlorothiazide

EXPERIMENTAL

300 mg and 25 mg tablet

Drug: Irbesartan and Hydrochlorothiazide

Avalide

ACTIVE COMPARATOR

irbesartan 300 mg and hydrochlorothiazide 25 mg

Drug: Avalide

Interventions

Irbesartan and Hydrochlorothiazide DRUG

Irbesartan and Hydrochlorothiazide

Avalide DRUG

Avalide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 and hydrochlorothiazide, 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.

Sponsors & Collaborators

• Roxane Laboratories: lead

Study Sites (1)

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

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jolene K Berg, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 23, 2012
• Study Start: September 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)