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Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers

NCT02243553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-09-18

No results posted yet for this study

Summary

Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir 500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.

Conditions

  • Healthy

Interventions

DRUG

Tipranavir capsule

DRUG

Tipranavir solution

DRUG

Ritonavir capsule

DRUG

Caffeine

DRUG

Warfarin sodium

DRUG

Vitamin K

DRUG

Omeprazole

DRUG

Dextromethorphan hydrobromide

DRUG

Midazolam injection

DRUG

Midazolam oral solution

DRUG

Digoxin tablet

DRUG

Digoxin injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-07-31

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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 NCT02243553 on ClinicalTrials.gov