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Trial record 13 of 443 for:    Hydrochlorothiazide

Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01149486
Recruitment Status : Completed
First Posted : June 23, 2010
Results First Posted : September 14, 2010
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Brief Summary:
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck & Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Losartan potassium/Hydrochlorothiazide Drug: Hyzaar® Phase 1

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Relative Bioavailability Study of 100/25 mg Losartan Potassium/Hydrochlorothiazide Tablets Under Fasting Conditions
Study Start Date : January 2004
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004


Arm Intervention/treatment
Experimental: Generic Test Product
Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets
Drug: Losartan potassium/Hydrochlorothiazide
100/25 mg Tablets

Active Comparator: Reference Listed Drug
Hyzaar® 100/25 mg Tablets
Drug: Hyzaar®
100/25 mg Tablets
Other Name: Losartan potassium/Hydrochlorothiazide (generic name)




Primary Outcome Measures :
  1. Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on Losartan Cmax.

  2. AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on Losartan AUC0-t.

  3. AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on Losartan AUC0-inf.

  4. Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on Hydrochlorothiazide Cmax.

  5. AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on Hydrochlorothiazide AUC0-t.

  6. AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on Hydrochlorothiazide AUC0-inf.


Secondary Outcome Measures :
  1. Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.

  2. AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.

  3. AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women, 18-45 years of age (inclusive).
  • Body mass index should be less than or equal to 30
  • Screening procedures completed within 28 days prior to dosing.
  • If female and:

    • of child bearing potential, is practicing an acceptable barrier method of birth control for the duration of the study
    • is postmenopausal for at least 1 year
    • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

  • Subjects with a recent history of drug or alcohol abuse or addiction.
  • Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
  • Subjects whose clinical laboratory test values the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
  • Subjects demonstrating a positive drug abuse screen when screened for the study.
  • Female subjects demonstrating a positive pregnancy screen.
  • Female subjects who are currently breastfeeding.
  • Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or hormonal contraceptives within 14 days of dosing will not be allowed to participate.
  • Subjects with a history of allergic response(s) to losartan, hydrochlorothiazide or related drugs.
  • Subjects with a history of clinically significant allergies including drug allergies.
  • Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).
  • Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to dosing.
  • Subjects who have used tobacco products within 90 days of Period 1 dose administration.
  • Subjects who report donating greater than 150 mL of blood within 14 days prior to dosing.
  • Subjects who report receiving any investigational drug within 28 days prior to dosing.
  • Subjects who report taking any systemic prescription medication in the 14 days prior to dosing.
  • Subjects who report an intolerance of direct venipuncture.
  • Subjects who report consuming an abnormal diet within the 28 days prior to dosing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149486


Locations
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United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
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Principal Investigator: James D Carlson, Pharm. D. PRACS Institute, Ltd.

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Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01149486     History of Changes
Other Study ID Numbers: R04-080
First Posted: June 23, 2010    Key Record Dates
Results First Posted: September 14, 2010
Last Update Posted: December 8, 2010
Last Verified: November 2010
Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects
Additional relevant MeSH terms:
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Hydrochlorothiazide
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators