A clinical trial to study bioequivalence between 2 formulations of drug called Aliskiren in healthy subjects
Phase 1
- Registration Number
- CTRI/2010/091/002815
- Lead Sponsor
- ovartis Healthcare Pvt. Ltd.Raheja IT Park, Mind Space - Bld # 6, Hitech City,Village - Madhapur,Hyderabad 500081, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Healthy male and female subjects age 18 to 55 years
Subjects must weigh at least 50 kg and BMI within 18 to 30 kg/m2
Able to communicate well with the investigator,
Exclusion Criteria
Smokers who report cigarette use of more than 5 cigarettes per day.
Subjects who use any prescription drugs, herbal supplements, OTC drugs or diet suppliments
A past medical history of clinically significant ECG abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method