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 |
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials