Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects.
|ClinicalTrials.gov Identifier: NCT00416468|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : June 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Aliskiren Drug: Valsartan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Randomized, Two-Treatment, Two Period Crossover, Single-Dose Study to Determine the Relative Bioavailability of Fixed Combination of Final Market Image (FMI) Aliskiren/Valsartan 75/160 mg Tablets and the Free Combination of Aliskiren 75 mg and Valsartan 160 mg in Healthy Subjects|
|Study Start Date :||November 2006|
- The relative bioavailability of the fixed dose combination of aliskiren/valsartan versus the free combination of aliskiren and valsartan via PK samples at pre-determined time points from pre-dose to 96 hours post-dose.
- To characterize the fixed dose combination of aliskiren/valsartan via Pk samples at pre-determines time points.
- The safety and tolerability of a single oral dose of a fixed and free combination aliskiren/valsartan.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416468
|United States, New Jersey|
|Novartis Investigative Site|
|East Hanover, New Jersey, United States, 07936-1080|
|Principal Investigator:||Novartis||Investigator site|