MedTrace Logo

Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir

NCT00817765 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-11-12

No results posted yet for this study

Summary

The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is to determine the safety of combined use of fosamprenavir with posaconazole in healthy volunteers.

Conditions

Interventions

DRUG

Posaconazole

Posaconazole oral solution 40mg/mL; 400mg BID treatment for 10 days, including dose escalation

DRUG

Fosamprenavir

fosamprenavir tablet 700mg; 1 tablet BID for 10 days

DRUG

Ritonavir

Ritonavir 100mg capsule; 1 capsule BID for 10 days

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • David M Burger, PharmD PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-07-31
Completion
2009-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00817765 on ClinicalTrials.gov