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
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