Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin
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|ClinicalTrials.gov Identifier: NCT00736697|
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : February 15, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: moxidectin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Randomized, Single-Dose, Parallel-Group Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Moxidectin Administered Orally to Healthy Subjects|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
- Blood samples [ Time Frame: 4 months ]
- Electrocardiograms [ Time Frame: 4 months ]
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Men or women of non childbearing potential aged 18 to 50 years inclusive at screening.
- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg.
- Any clinical important deviation from normal limits in physical examination findings, vital sign measurements, electrocardiograms or clinical laboratory test results.
- Presence or history of any disorder that may prevent the successful completion of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736697
|Poitiers, France, 86000|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Responsible Party:||Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth|
|Other Study ID Numbers:||
|First Posted:||August 18, 2008 Key Record Dates|
|Last Update Posted:||February 15, 2011|
|Last Verified:||February 2011|