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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:December 2015
End Date:December 2015

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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.
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