Assessment of the Effect of Food on ABT-143 Bioavailability

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic Variables

Treatments: Drug: ABT-143 (rosuvastatin calcium and fenofibric acid ); Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719693

M10-442

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

A

Experimental group

Description:

ABT-143 under low-fat meal condition

Treatment:

Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )

B

Experimental group

Description:

ABT-143 under fasting meal condition

Treatment:

Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )