A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
NCT ID: NCT02634034
Last Updated: 2016-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2015-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)
A: NK-104-CR 8 mg
NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
B: Pitavastatin IR 4 mg
Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
C: Pitavastatin IR 8 mg
Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)
A: NK-104-CR 8 mg
NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
B: Pitavastatin IR 4 mg
Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
C: Pitavastatin IR 8 mg
Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)
A: NK-104-CR 8 mg
NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
B: Pitavastatin IR 4 mg
Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
C: Pitavastatin IR 8 mg
Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Interventions
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A: NK-104-CR 8 mg
NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
B: Pitavastatin IR 4 mg
Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
C: Pitavastatin IR 8 mg
Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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Austin, Texas, United States
Countries
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Other Identifiers
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NK-104-CR-1.01US
Identifier Type: -
Identifier Source: org_study_id
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