Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg) | Experimental |
| |
| Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg) | Experimental |
| |
| Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A: NK-104-CR 8 mg | Drug | NK-104-CR 8 mg (Controlled Release single 8-mg tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve | Area Under the Curve 0 to tau | 0 to 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
Not provided
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
|