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NCT00681525 Clinical Trial

A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

Pharmacokinetics Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00681525
Other study ID # M10-367
Secondary ID
Status Completed
Phase Phase 1
First received May 19, 2008
Last updated October 18, 2010
Start date April 2008

Study information
Verified date September 2010
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male or female subjects

Exclusion Criteria:

- Clinically significant diseases or disorders

- Positive screens for drug and alcohol

- Pregnant or breast-feeding females

- Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABT-335
One ABT-335 135 mg capsule QD for 10 days
• Atorvastatin
One 80 mg tablet of atorvastatin QD for 10 days
• Ezetimibe
One ezetimibe 10 mg tablet QD for 10 days

Locations
Country Name City State
United States Site Reference ID/Investigator# 8087 Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PK interaction Study duration approximately 62 days Yes
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