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

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ClinicalTrials.gov Identifier: NCT01712126
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

October 19, 2012
October 23, 2012
January 23, 2018
September 2007
September 2007   (Final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT01712126 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan / Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
  • Drug: Irbesartan and Hydrochlorothiazide
  • Drug: Avalide
  • Experimental: Irbesartan and Hydrochlorothiazide
    300 mg and 25 mg tablet
    Intervention: Drug: Irbesartan and Hydrochlorothiazide
  • Active Comparator: Avalide
    irbesartan 300 mg and hydrochlorothiazide 25 mg
    Intervention: Drug: Avalide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
September 2007
September 2007   (Final data collection date for primary outcome measure)

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 and hydrochlorothiazide, 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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01712126
IRHY-T300-PVFD-1
No
Not Provided
Not Provided
West-Ward Pharmaceutical ( Roxane Laboratories )
Roxane Laboratories
Not Provided
Principal Investigator: Jolene K Berg, MD Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
West-Ward Pharmaceutical
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP