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Assessment of the Effect of Food on ABT-143 Bioavailability

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00719693
Enrollment
115
Registered
2008-07-22
Start date
2008-07-31
Completion date
Unknown
Last updated
2012-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic Variables

Keywords

Food effect, phase I, adverse events

Brief summary

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

Interventions

DRUGABT-143 ( rosuvastatin calcium and fenofibric acid )

one dose under low-fat meal condition

DRUGABT-143 (rosuvastatin calcium and fenofibric acid )

one dose under fasting meal condition

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics7 days

Secondary

MeasureTime frame
Adverse Events30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026