A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
- Registration Number
- NCT01363999
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy volunteers, 18 to 55 years of age, inclusive
Exclusion Criteria
- Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
- Clinically significant abnormal laboratory values
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description D dalcetrapib RO4607381/F49 tablet A dalcetrapib RO5317116/F01 bilayer tablet A atorvastatin RO5317116/F01 bilayer tablet B dalcetrapib RO5317116/F03 bilayer tablet B atorvastatin RO5317116/F03 bilayer tablet C atorvastatin RO5317116/F04 active-coated tablet C dalcetrapib RO5317116/F04 active-coated tablet D atorvastatin RO4607381/F49 tablet
- Primary Outcome Measures
Name Time Method Plasma Concentration of Dalcetrapib Active Form 3 days Plasma Concentration of Atorvastatin 3 days
- Secondary Outcome Measures
Name Time Method Safety: Incidence of Serious Adverse Events 9 weeks Plasma Concentration of Atorvastatin Metabolites 3 days Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.