A study to compare the concentrations of valsartan in plasma when valsartan is taken as solution formulation and as tablet formulation.
Phase 1
Completed
- Registration Number
- CTRI/2010/091/001094
- Lead Sponsor
- ovartis Healthcare Private Limited Andhra Pradesh India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Healthy males and postmenopausal or surgically sterilized women of 18 to 45 years of age who grant informed consent
Exclusion Criteria
Smokers, drug addicts, those having immunodeficiency diseases
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the bioavailability of valsartan between the valsartan oral solution formulation and valsartan tablet (Diovan®) formulation.Timepoint: End of the trial
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of valsartan oral solution and tablet formulationsTimepoint: End of trial;To perform exploratory pharmacogenetic assessments to examine whether individual genetic variation in genes relating to drug metabolism and the drug target pathway confer differential response to valsartan.Timepoint: End of trial;To perform palatability assessment of the formulationsTimepoint: End of trial