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Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fasted Conditions

Not Applicable
Completed
Conditions
Hypertension
Registration Number
NCT01216852
Lead Sponsor
Roxane Laboratories
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
bioequivalence determined by statistical comparison Cmax15 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Bio-Kinetic Clinical Applications, Inc.

🇺🇸

Springfield, Missouri, United States

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