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

Abbott

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Atorvastatin; Drug: ABT-335; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681525

M10-367

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

A

Experimental group

Description:

ABT-335 135 mg

Treatment:

Drug: ABT-335

B

Experimental group

Description:

Atorvastatin 80 mg and Ezetimibe 10 mg

Treatment:

Drug: Ezetimibe

Drug: Atorvastatin

C

Experimental group

Description:

ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg

Treatment:

Drug: ABT-335

Drug: Ezetimibe

Drug: Atorvastatin