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PK of Anidulafungin in Normal, Overweight and Obese Volunteers
NCT01307930Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2011
- Primary completion
- Nov 2012
- Countries
- 1
- Sponsor
- Texas Tech University Health Sciences Center
- Modality
- Small Molecules, Cyclic Peptides
- Drugs
- anidulafungin
- Conditions
- candidiasisfungal infection
01
Overview
Phase 4, open-label, single-arm trial of anidulafungin in candidiasis and fungal infection, sponsored by Texas Tech University Health Sciences Center. Primary endpoint: Serum Clearance of Anidulafungin. Started Jan 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Anidulafungin
Volunteers stratified by BMI receiving single dose Anidulafungin
03
Who it enrols
Adult volunteers with varying BMI (normal, overweight, obese) without fungal infection or liver dysfunction.
04
Endpoints
Primary
Serum Clearance of Anidulafungin
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