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

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ClinicalTrials.gov Identifier: NCT01102478
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Hypertension Drug: losartan potassium / hydrochlorothiazide

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2005
Primary Completion Date : March 2005
Study Completion Date : March 2005


Arms and Interventions

Intervention Details:
    Drug: losartan potassium / hydrochlorothiazide
    100 mg / 25 mg tablet
    Other Name: Hyzaar

Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence determined by statistical comparison Cmax [ Time Frame: 25 days ]

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • 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

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): 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

Responsible Party: Elizabeth Ernst, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01102478     History of Changes
Other Study ID Numbers: LOHY-T100/25-PVFS-1
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010

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