Assessment of potential effects of elinogrel on steady-state pharmacokinetics of atorvastatin in healthy adult subjects
Phase 1
Completed
- Conditions
- acute coronary syndromesCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12610000640000
- Lead Sponsor
- ucleus Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
adult subjects aged 18 to 45
- Body Mass Index (BMI) between 18 and 32 Kg/m2
- Change between seated and standing blood pressure less than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure.
Exclusion Criteria
- Women of childbearing potential unless using suitable contraception methods
- Bleeding time tests out of normal laboratory range
- Abnormal liver function test results
- Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic samples. <br>Steady state pharmacokinetics of multiple doses of atorvastatin when adminstered with and without elinogrel in healthy adults[24 hours after the morning dose given on day 5 of each treatment period]
- Secondary Outcome Measures
Name Time Method Safety assessments (electrocardiogram (ECG), vitals signs including pulse rate, blood pressure, body temperature, safety bloods, hematology, biochemistry and urinalysis, bleeding time tests, fecal occult blood, adverse events and serious adverse events)[From the time of first dose until the end of study visit.]