Assessment of the Effect of Food on ABT-143 Bioavailability

Phase 1CompletedNCT00719693

AstraZeneca115 enrolled

Overview

Single-dose, open-label, two-period crossover study of ABT-143

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

115

Conditions

Pharmacokinetic Variables

Interventions

ABT-143 ( rosuvastatin calcium and fenofibric acid )DRUG

one dose under low-fat meal condition

ABT-143 (rosuvastatin calcium and fenofibric acid )DRUG

one dose under fasting meal condition

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Site Reference ID/Investigator# 9242

Evansville, Indiana, United States

Outcomes

Primary Outcomes

Pharmacokinetics

Time frame: 7 days

Secondary Outcomes

Adverse Events

Time frame: 30 days

Data from ClinicalTrials.gov

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