A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers

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.

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.