Assessment of the Effect of Food on ABT-143 Bioavailability
Phase 1
Completed
- Conditions
- Pharmacokinetic Variables
- Interventions
- Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )
- Registration Number
- NCT00719693
- Lead Sponsor
- AstraZeneca
- Brief Summary
Single-dose, open-label, two-period crossover study of ABT-143
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
Inclusion Criteria
- 18-55 years of age (inclusive)
- BMI 19 to 29 inclusive
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Exclusion Criteria
- Asian ancestry
- Concurrent participation in another study
- Females pregnant or breastfeeding
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A ABT-143 ( rosuvastatin calcium and fenofibric acid ) ABT-143 under low-fat meal condition B ABT-143 (rosuvastatin calcium and fenofibric acid ) ABT-143 under fasting meal condition
- Primary Outcome Measures
Name Time Method Pharmacokinetics 7 days
- Secondary Outcome Measures
Name Time Method Adverse Events 30 days
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 9242
🇺🇸Evansville, Indiana, United States