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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681525

Enrollment

Registered

2008-05-21

Start date

2008-04-30

Completion date

Unknown

Last updated

2010-10-19

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

Conditions

Pharmacokinetics

Brief 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.

Interventions

DRUGABT-335

One ABT-335 135 mg capsule QD for 10 days

DRUGAtorvastatin

One 80 mg tablet of atorvastatin QD for 10 days

DRUGEzetimibe

One ezetimibe 10 mg tablet QD for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
PK interaction	Study duration approximately 62 days

Countries

United States

Outcome results

None listed

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