Hyperlipidemia
Conditions
Brief summary
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
Interventions
DRUGA: NK-104-CR 8 mg
NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
DRUGB: Pitavastatin IR 4 mg
Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
DRUGC: Pitavastatin IR 8 mg
Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject provides written informed consent before any study-specific evaluation is performed. * Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive. * Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator. * Subject is able and willing to comply with the protocol and study procedures.
Exclusion criteria
* Subject is a woman who is pregnant or breastfeeding. * Subject has clinically relevant abnormalities in the screening or check-in assessments. * Subject has received an investigational drug within 30 days before the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve | 0 to 48 hours | Area Under the Curve 0 to tau |
Countries
United States
Outcome results
None listed