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A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aspergillosis; Candidemia

Intervention: anidulafungin and voriconazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.

Clinical Details

Official title: A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)

Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)

Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)

Plasma PK: Plasma Elimination Half-life (t1/2)

Plasma PK: Total Clearance (CL Total)

Plasma PK: Volume of Distribution at Steady-state (Vss)

Epithelial Lining Fluid (ELF) PK: Cmax

ELF PK: Tmax

ELF PK: AUCtau

ELF PK: t1/2

Alveolar Macrophages (AM): Cmax

AM: Tmax

AM: AUCtau

AM: t1/2

Overall Drug Penetration Ratio in ELF

Concentration Ratio in ELF to Plasma

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy adult subjects willing to comply with the study requirement.

Exclusion Criteria:

- Clinical significant disease.

- Sensitive to study medication.

- Not willing to comply with the study requirement.

Locations and Contacts

Pfizer Investigational Site, Hartford, Connecticut 06102, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2008
Last updated: January 5, 2010

Page last updated: August 23, 2015

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