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

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Kowa

Status and phase

Completed
Phase 1

Conditions

Hyperlipidemia

Treatments

Drug: B: Pitavastatin IR 4 mg
Drug: A: NK-104-CR 8 mg
Drug: C: Pitavastatin IR 8 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02634034
NK-104-CR-1.01US

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy 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.

Trial design

18 participants in 3 patient groups

NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)
Experimental group
Treatment:
Drug: A: NK-104-CR 8 mg
Drug: C: Pitavastatin IR 8 mg
Drug: B: Pitavastatin IR 4 mg
Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)
Experimental group
Treatment:
Drug: A: NK-104-CR 8 mg
Drug: C: Pitavastatin IR 8 mg
Drug: B: Pitavastatin IR 4 mg
Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)
Experimental group
Treatment:
Drug: A: NK-104-CR 8 mg
Drug: C: Pitavastatin IR 8 mg
Drug: B: Pitavastatin IR 4 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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