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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00940017
Other study ID # A8851020
Secondary ID
Status Completed
Phase Phase 4
First received July 13, 2009
Last updated January 5, 2010
Start date September 2008
Est. completion date October 2008

Study information

Verified date January 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
anidulafungin and voriconazole
Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.

Locations

Country Name City State
United States Pfizer Investigational Site Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion No
Primary Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax) 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion No
Primary Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau) 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion No
Primary Plasma PK: Plasma Elimination Half-life (t1/2) 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion No
Primary Plasma PK: Total Clearance (CL Total) 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion No
Primary Plasma PK: Volume of Distribution at Steady-state (Vss) 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion No
Primary Epithelial Lining Fluid (ELF) PK: Cmax 4, 8, 12, 24 hours after start of infusion No
Primary ELF PK: Tmax 4, 8, 12, 24 hours after start of infusion No
Primary ELF PK: AUCtau 4, 8, 12, 24 hours after start of infusion No
Primary ELF PK: t1/2 4, 8, 12, 24 hours after start of infusion No
Primary Alveolar Macrophages (AM): Cmax 4, 8, 12, 24 hours after start of infusion No
Primary AM: Tmax 4, 8, 12, 24 hours after start of infusion No
Primary AM: AUCtau 4, 8, 12, 24 hours after start of infusion No
Primary AM: t1/2 4, 8, 12, 24 hours after start of infusion No
Primary Overall Drug Penetration Ratio in ELF 4, 8, 12, 24 hours after start of infusion No
Primary Concentration Ratio in ELF to Plasma 4, 8, 12, 24 hours after start of infusion No
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