Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin
NCT00736697
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- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin | |||
Official Title ICMJE | 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 | |||
Brief Summary | The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) | |||
Condition ICMJE | Infection | |||
Intervention ICMJE | Drug: moxidectin | |||
Study Arms ICMJE | Experimental: 1
Intervention: Drug: moxidectin | |||
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 | 54 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2009 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion criteria
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00736697 | |||
Other Study ID Numbers ICMJE | 3110A1-1005 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |