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

Kowa

Status and phase

Completed

Phase 1

Conditions

Hyperlipidemia

Treatments

Drug: B: Pitavastatin IR 4 mg

Drug: A: NK-104-CR 8 mg

Drug: C: Pitavastatin IR 8 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02634034

NK-104-CR-1.01US

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy 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.