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

Phase 1

Completed

• Conditions: Hyperlipidemia

• Registration Number: NCT02634034
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Area Under the Curve	0 to 48 hours	Area Under the Curve 0 to tau