- Healthy adult subjects willing to comply with the study requirement.
- Clinical significant disease.
- Sensitive to study medication.
- Not willing to comply with the study requirement.
The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to
determine the drug concentration in the lung.
- Healthy adult subjects willing to comply with the study requirement.
- Clinical significant disease.
- Sensitive to study medication.
- Not willing to comply with the study requirement.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center
Descriptive Information | ||||
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Brief Title ICMJE | A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects | |||
Official Title ICMJE | A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects | |||
Brief Summary | The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) |
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Condition ICMJE |
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Intervention ICMJE | 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.
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Study Arms | Experimental: 1
Intervention: Drug: anidulafungin and voriconazole
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 24 | |||
Completion Date | October 2008 | |||
Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00940017 | |||
Other Study ID Numbers ICMJE | A8851020 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.
Pfizer Clinical Trials Contact Center
1-800-718-1021