Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions

Roxane Laboratories30 enrolled

Overview

The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

losartan potassium / hydrochlorothiazideDRUG

100 mg / 25 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 hydrochlorothiazide or any comparable or similar product.

Locations (1)

CEDRA Clinical Research, LLC

Austin, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence determined by statistical comparison Cmax

Time frame: 25 days

Data from ClinicalTrials.gov

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