Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg

AstraZeneca90 enrolled

Overview

The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ABT-143DRUG

Once, please see Arm Description for more details.

ABT-335DRUG

Once, see Arm Description for more detail

rosuvastatinDRUG

once, see Arm Description for more detail

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: 1. A condition of general good health 2. BMI 19 to 29 Exclusion Criteria: 1. Currently enrolled in another clinical study 2. Females who are pregnant or breast-feeding

Locations (1)

Site Reference ID/Investigator# 13441

Orlando, Florida, United States

Outcomes

Primary Outcomes

To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.

Time frame: 7 days

To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.

Time frame: 7 days

Data from ClinicalTrials.gov

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