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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ABT-335; Drug: ABT-143; Drug: rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00826358

M10-535

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

A

Experimental group

Description:

ABT-143 capsules 5/45mg

Treatment:

Drug: ABT-143

B

Active Comparator group

Description:

ABT-335 45mg and rosuvastatin 5mg

Treatment:

Drug: rosuvastatin

Drug: ABT-335