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Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01102478
First received: April 9, 2010
Last updated: April 12, 2010
Last verified: April 2010
History of Changes
  Purpose

The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.


Condition Intervention
Hypertension
 Drug: losartan potassium / hydrochlorothiazide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence determined by statistical comparison Cmax [ Time Frame: 25 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2005
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: losartan potassium / hydrochlorothiazide
    100 mg / 25 mg tablet
    Other Name: Hyzaar
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102478

Locations
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Daniel V Freeland, D.O. CEDRA Clinical Research, LLC
  More Information

No publications provided

Responsible Party: Elizabeth Ernst, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01102478     History of Changes
Other Study ID Numbers: LOHY-T100/25-PVFS-1
Study First Received: April 9, 2010
Last Updated: April 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 13, 2013