A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
NCT00855101
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy male and female subjects from 18 and 55 years old.
- Body weight between 40 kg (88 lbs) and 100 kg (220 lbs).
- Subjects with evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, ocular,
neurologic, or allergic disease.
- Subjects with any condition possibly affecting drug absorption, eg, gastrectomy.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of study medication.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Neptune, New Jersey
- Baltimore, Maryland
- Overland Park, Kansas
- Shanghai,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults | |||
Official Title ICMJE | An Open-Label, Intravenous (6/4 Mg/Kg Q12h) To Oral Switch (200 Mg Q12h), Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Healthy Male And Female Adults | |||
Brief Summary | This study is to assess the plasma concentration-time profile of voriconazole in adults receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to assess the safety profile of voriconazole during the treatment period. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
Condition ICMJE | Healthy Volunteers | |||
Intervention ICMJE | Drug: voriconazole
6 mg/kg IV q12h on Day 1, and 4 mg/kg IV q12h on Days 2-7, then switch to 200 mg oral tablet q12h on Days 8-14. Other Name: Vfend | |||
Study Arms ICMJE | Experimental: voriconazole
Intervention: Drug: voriconazole | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 35 | |||
Original Estimated Enrollment ICMJE | 32 | |||
Actual Study Completion Date ICMJE | July 2009 | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00855101 | |||
Other Study ID Numbers ICMJE | A1501092 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | June 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |