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History of Changes for Study: NCT01218711
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 Fasting Conditions.
Latest version (submitted October 23, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 8, 2010 None (earliest Version on record)
2 October 23, 2017 Study Status
Comparison Format:

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Study NCT01218711
Submitted Date:  October 8, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: PK-07-067
Brief Title: 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 Fasting Conditions.
Official Title: 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 Fasting Conditions.
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2010
Overall Status: Completed
Study Start:
Primary Completion:
Study Completion:
First Submitted: October 7, 2010
First Submitted that
Met QC Criteria:
October 8, 2010
First Posted: October 11, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 8, 2010
Last Update Posted: October 11, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Torrent Pharmaceuticals Limited
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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

Detailed Description:
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 1
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: Losartan Potassium and Hydrochlorothiazide Tablets
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Bioequivalence based AUC parameters
2. Bioequivalence based on Cmax
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers:
Criteria:

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.
Open or close this module Contacts/Locations
Locations:
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Plan to Share IPD:
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Citations:
Links:
Available IPD/Information:

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