Assessment of the Effect of Food on ABT-143 Bioavailability

Pharmacokinetic Variables Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719693
• Other study ID #: M10-442
• Status: Completed
• Phase: Phase 1
• First received: July 18, 2008
• Last updated: September 27, 2012
• Start date: July 2008

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetic Variables

Intervention

Drug:
• ABT-143 ( rosuvastatin calcium and fenofibric acid )
one dose under low-fat meal condition
• ABT-143 (rosuvastatin calcium and fenofibric acid )
one dose under fasting meal condition

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 9242	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		7 days	No
Secondary	Adverse Events		30 days	Yes