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

NCT02634034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-01-11

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02634034 on ClinicalTrials.gov