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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
GroupInterventionDescription
AABT-143 ( rosuvastatin calcium and fenofibric acid )ABT-143 under low-fat meal condition
BABT-143 (rosuvastatin calcium and fenofibric acid )ABT-143 under fasting meal condition
Primary Outcome Measures
NameTimeMethod
Pharmacokinetics7 days
Secondary Outcome Measures
NameTimeMethod
Adverse Events30 days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 9242

🇺🇸

Evansville, Indiana, United States

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