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Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)

NCT00977301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-11-30

No results posted yet for this study

Summary

The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose of olanzapine will be studied.

In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the CYP1A2 and UGT metabolism of olanzapine.

Conditions

  • HIV Infections

Interventions

DRUG

fosamprenavir/ritonavir

16 days 700mg/100mg RTV BID

DRUG

olanzapine

15 mg olanzapine single dose

DRUG

olanzapine

10 mg olanzapine single dose

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • David 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
2009-11-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT00977301 on ClinicalTrials.gov