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Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

NCT01057433 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-06-22

Study results available
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Summary

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Pitavastatin (NK-104)

pitavastatin (NK-104) 4 mg once daily (QD)

DRUG

Lopinavir/ritonavir

lopinavir/ritonavir 800 mg/200 mg

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger Morgan, MD, FACS · Kowa Research Institute, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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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 NCT01057433 on ClinicalTrials.gov