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Completed

NCT Number: NCT01216852

Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fasted Conditions

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bio-Kinetic Clinical Applications, Inc.

Springfield, Missouri, 65802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 or any comparable or similar product.

Treatment and study plan

Losartan Potassium

Drug

100 mg tablet

Other names: COZAAR

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, 2-Period, 2-Treatment Bioequivalency Study of Losartan Potassium Tablets 100 mg Under Fasted Conditions

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Oct 7, 2010
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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