A randomised parallel-group pharmacokinetic study to evaluate the bioequivalence of different formulations of moxidectin in adults

  • Vaillant, Michel (PI)
  • Sullivan, Mark (CoPI)
  • Batchelor, Hannah (CoPI)
  • Opoku, Nicholas O. (CoPI)

Project Details

Description

The primary objective of this study is to compare the bioavailability of new oral formulation(s) of moxidectin with the bioavailability of moxidectin tablets, 2mg. Adult volunteers will take a single dose of moxidectin 8 mg as either (4 x 2 mg) tablets or as an alternative oral formulation suitable for administration to children. Blood samples will be taken from each participant at pre-specified intervals after dosing for determination of moxidectin blood levels. The range of exposures (concentration of moxidectin in blood over time) in each treatment group will be compared to determine whether the new formulation(s) deliver the same amount of drug as the tablets and are therefore bioequivalent.
AcronymMiniMox
StatusActive
Effective start/end date1/01/2130/07/25

Funding

  • European and Developing Countries Clinical Trials Partnership (EDCTP): €678,640.00
  • FNR - Fonds National de la Recherche: €724,000.00

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