NCT02634034

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	A: NK-104-CR 8 mg	NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
DRUG	B: Pitavastatin IR 4 mg	Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
DRUG	C: Pitavastatin IR 8 mg	Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)

Timeline

• Start date: 2015-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-12-17
• Last updated: 2016-01-11

Locations

1 site across 1 country: United States