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Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

NCT01422369 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-07-13

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

Pitavastatin (NK-104)

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

DRUG

Darunavir/Ritonavir (Prezista)

Darunavir/Ritonavir (Prezista) 800 mg/100 mg

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

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 NCT01422369 on ClinicalTrials.gov