Pharmacokinetic Variables
Conditions
Keywords
Food effect, phase I, adverse events
Brief summary
Single-dose, open-label, two-period crossover study of ABT-143
Interventions
DRUGABT-143 ( rosuvastatin calcium and fenofibric acid )
one dose under low-fat meal condition
DRUGABT-143 (rosuvastatin calcium and fenofibric acid )
one dose under fasting meal condition
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-55 years of age (inclusive) * BMI 19 to 29 inclusive
Exclusion criteria
* Asian ancestry * Concurrent participation in another study * Females pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | 30 days |
Countries
United States
Outcome results
None listed