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A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting Conditions

NCT03459911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-11-02

No results posted yet for this study

Summary

To demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with reference Cozaar® (containing Losartan potassium 100 mg) of "Merck Sharpe \& Dohme B.V.", Haarlem, the Netherlands in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety

Conditions

  • Healthy

Interventions

DRUG

Cozaar 100mg Tablet

Cozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe \& Dohme B.V. , Haarlem, the Netherlands)

DRUG

Losartan potassium 100mg

Losartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus)

Sponsors & Collaborators

  • Reliance Life Sciences Private Limited

    collaborator INDUSTRY

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Suresh A Maroli, MD · Reliance Life Sciences Pvt. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2018-03-11
Completion
2018-03-16

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459911 on ClinicalTrials.gov