Skip to main content
OpenTrials
Completed

NCT Number: NCT02634034

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A: NK-104-CR 8 mg

Drug

NK-104-CR 8 mg (Controlled Release single 8-mg tablet)

B: Pitavastatin IR 4 mg

Drug

Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)

C: Pitavastatin IR 8 mg

Drug

Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)

Primary outcomes

  1. Area Under the Curve

    Time frame: 0 to 48 hours

    Area Under the Curve 0 to tau

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2015
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.