Phase 1
Completed N=77
Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
Source: ClinicalTrials.gov NCT00953680 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Area Under the Curve (AUC(0 to Infinity)) of Losartan — 1018.1; 1024.9 ng*hr/mL
Summary
This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC(0 to Infinity)) of Losartan |
1018.1; 1024.9 | — |
| PRIMARY Peak Plasma Concentration (Cmax) for Losartan |
532.7; 637.9 | — |
| PRIMARY Area Under the Curve (AUC(0 to Infinity)) of HCTZ |
462.08; 499.90 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ |
76.15; 81.76 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is a healthy male or female between the ages of 18 and 45 years of age
- Subject does not smoke
Exclusion Criteria
- Subject has a history of any illness that might pose additional risk to participation or confound the results of the study
- Subject has a history of hepatitis B or C or significant drug allergies
Data sourced from ClinicalTrials.gov (NCT00953680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.