Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fed Conditions

Overview

Objective: to compare the single dose bioavailability of Torrent's Losartan Potassium and Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co., Inc. Study Design: Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects

Full Title of Study: “An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Fixed Dose Combination (FDC) of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fed Conditions”

Study Type

  • Study Type: Interventional

Interventions

  • Drug: Losartan Potassium and Hydrochlorothiazide Tablets

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on AUC parameters
  • Bioequivalence based on Cmax

Participating in This Clinical Trial

Inclusion Criteria

  • The volunteers were excluded from the study based on the following criteria: – Sex: male. – Age: 18 – 45 years. . – Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. – Healthy and willing to participate in the study. – Volunteer willing to adhere to the protocol requirements and to provide written informed consent. – Non-smokers or smoker who smokes less than 10 cigarettes per day Exclusion Criteria:

  • The volunteers were excluded from the study based on the following criteria: – Clinically relevant abnormalities in the results of the laboratory screening evaluation. – Clinically significant abnormal ECG or Chest X-ray. – Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. – Pulse rate less than 50/minute or more than 100/minute. – Oral temperature less than 95°P or more than 98.6°P. – Respiratory rate less than 12/minute or more than 20/minute – History of allergy to the test drug or any drug chemically similar to the drug under investigation. – History of alcohol or drug abuse – Positive breath alcohol test – Recent history of kidney or liver dysfunction. – History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study. – Volunteers suffering from any chronic illness such as arthritis, asthma etc. – History of heart failure. – HIV, HCV, HBsAg positive volunteers. – Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test. – Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. – Administration of any study drug in the period 0 to 3 months before entry to the study. – History of significant blood loss due to any reason, including blood donation in the past 3 months. – History of pre-existing bleeding disorder. – Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. – Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Investigator Details

  • Lead Sponsor
    • Torrent Pharmaceuticals Limited

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