Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Adverse Events; Pharmacokinetic Variables

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728780

M10-586

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Condition of good health

Exclusion criteria

• Currently enrolled in another study
• 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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32 participants in 2 patient groups

A

Experimental group

Description:

ABT-143 15/135mg

Treatment:

Drug: ABT-143

B

Active Comparator group

Description:

ABT-335 135mg and rosuvastatin 15mg

Treatment:

Drug: ABT-335 and rosuvastatin