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.

Adverse Events Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728780
• Other study ID #: M10-586
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2008
• Last updated: September 27, 2012
• Start date: August 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• Condition of good health

Exclusion Criteria:

• Currently enrolled in another study

• Females who are pregnant or breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Events
• Pharmacokinetic Variables

Intervention

Drug:
• ABT-143
once
• ABT-335 and rosuvastatin
once

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 11101	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	Adverse events and safety laboratory assessments		7 days	Yes
Primary	Pharmacokinetic parameters		7 days	No