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An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence After Administration of a Losartan 100-mg/Hydrochlorothiazide 12.5-mg Combination Tablet and the Coadministration of a Currently Marketed COZAAR™ 100-mg Tablet and MICROZIDE™ 12.5 mg Capsule in Healthy Adults
This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 77 |
| Start date | 2004-04 |
| Completion | 2004-07 |
Conditions
- Hypertension
Interventions
- losartan potassium (+) hydrochlorothiazide (HCTZ)
- losartan potassium
- hydrochlorothiazide (HCTZ)
Primary outcomes
- Area Under the Curve (AUC(0 to Infinity)) of Losartan — 0 to 36 Hours Post Dose
- Peak Plasma Concentration (Cmax) for Losartan — 36 Hours Post Dose
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing. - Area Under the Curve (AUC(0 to Infinity)) of HCTZ — 0 to 30 Hours Post Dose
Plasma Area Under the Curve, a measure of drug exposure following dosing - Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ — 30 Hours Post Dose
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing