Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects.
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|ClinicalTrials.gov Identifier: NCT00416728|
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)|
|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 150/80 mg Tablets and the Free Combination of Aliskiren 150 mg and Valsartan 80 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-determined time points.
- The safety and tolerability of a single oral dose of a fixed and free combination aliskiren/valsartan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416728
|United States, New Jersey|
|Novartis Investigative Site|
|East Hanover, New Jersey, United States, 07936-1080|
|Principal Investigator:||Novartis||Investigator site|