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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kowa Research Institute, Inc.
• Treatments: Pitavastatin

Criteria

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.