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

Pharmacokinetic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681395
• Other study ID #: M10-360
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2008
• Last updated: September 27, 2012
• Start date: May 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• General good health

• BMI 19 to 29

Exclusion Criteria:

• Currently enrolled in another study

• Females who are pregnant or breastfeeding

Study Design

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

Related Conditions & MeSH terms

• Adverse Events
• Pharmacokinetic

Intervention

Drug:
• ABT-143
once daily for 6 days
• ABT-335
once daily for six days
• Rosuvastatin
Once daily for 6 days

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 8089	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event and safety laboratory assessments		7 days	Yes
Primary	Pharmacokinetic parameters		7 days	No