A clinical trial to evaluate and compare the blood levels of aliskiren mini-tablets with aliskiren market tablet under fasted condition and futher evaluate aliskiren mini-tablets under fed condition in healthy subjects
Phase 1
- Registration Number
- CTRI/2009/091/000723
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 69
Inclusion Criteria
Healthy male and female subjects ( women of non-child bearing
potential)
Exclusion Criteria
Female subjects of child bearing potential. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the bioavailability of a single oral dose of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition in healthy subjects<br>To evaluate the effect of food on the pharmacokinetics of a single oral dose of 300 mg aliskiren mini-tablets in healthy subjectsTimepoint: Single Dose Of SPP100 Administration<br>Under Fasting Or Fed Condition Followed<br>By PK Sample Collection Till Day 8<br>(Except On Day 6)
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of a single oral dose of 300 mg aliskiren mini-tablets administered with or without meal and a single oral dose of 300 mg aliskiren market tablet in healthy subjects without meal, respectively.Timepoint: Number Of AEs From First Dosing To End Of Study Evaluation And Number Of SAEs From Date Of ICF To 4weeks After Last Dose Administration. Safety assessments will also include vital signs, blood pressure and pulse rate) standard clinical laboratory evaluations. Blood pressure, pulse rate: screening*, each baseline*, pre- dose* and 2, 4, 12 and 24* hours post dose, end of study* Note: measurements are supine, or supine and after 3 min standing if indicated by an *asterisk) Hematology; Blood chemistry; Urinalysis: screening, each baseline, end of study