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

Completed · Phase 1

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT02634034

Run by

Kowa Research Institute, Inc.

People needed

18

Starts

2015-12-01

Expected to finish

2015-12-01

Last updated by the study team

2016-01-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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