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
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
- Secondary Outcome Measures
Name Time Method