Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic; Adverse Events

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681395

M10-360

Details and patient eligibility

About

To evaluate 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: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• General good health
• BMI 19 to 29

Exclusion criteria

• Currently enrolled in another study
• Females who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

1

Experimental group

Description:

ABT-143 capsules 20/135 mg

Treatment:

Drug: ABT-143

2

Active Comparator group

Description:

ABT-335 135mg and rosuvastatin 20mg

Treatment:

Drug: Rosuvastatin

Drug: ABT-335

3

Experimental group

Description:

ABT-143 capsules 5/45mg

Treatment:

Drug: ABT-143

4

Active Comparator group

Description:

ABT-335 45mg and rosuvastatin 5mg

Treatment:

Drug: Rosuvastatin

Drug: ABT-335