A study to find out the variation in the absorption of SPA100 (aliskiren/amlodipine 300/10 mg oral tablets) when given with and with out food
Phase 1
Completed
- Registration Number
- CTRI/2009/091/000762
- Lead Sponsor
- ovartis Healthcare Private Limited,Andhra Pradesh, India 500 081.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Healthy male and post menopausal female subjects age 18 to 45 years ready for written informed consent
Exclusion Criteria
Heavy smokers, drug addicts and alcoholics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the bioavailability of aliskiren and amlodipine from a fixed combination aliskiren/amlodipine 300/10 mg oral tablets under fed and fasted conditionsTimepoint:
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of a single oral dose of a fixed combination of aliskiren/amlodipine 300/10 mg oral tabletsTimepoint: