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

A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fasting Conditions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01102478

Enrollment

Registered

2010-04-13

Start date

2005-02-28

Completion date

2005-03-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DRUGlosartan potassium / hydrochlorothiazide

100 mg / 25 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence determined by statistical comparison Cmax	25 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026