drugset / Trial / NCT02696954
Study of Artemether-lumefantrine, Amodiaquine and Primaquine in Healthy Subjects
Phase 1/2
Terminated
17 enrolled
University of Oxford
Mahidol Oxford Tropical Medicine Research Unit · collabMahidol University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective * To characterize the potential pharmacokinetic interactions of artemether -lumefantrine, amodiaquine and primaquine in healthy adult subjects. Secondary Objectives * To characterize the pharmacokinetic properties of artemether-lumefantrine, amodiaquine and primaquine when given alone and in combination. * To evaluate the safety and tolerability of co-administered artemether-lumefantrine, amodiaquine and primaquine. * To investigate pharmacogenetic polymorphisms affecting drug levels of artemether-lumefantrine, amodiaquine and primaquine and their metabolites.
Timeline
- Start
- 2016-11-18
- Primary completion
- 2019-03
- Completion
- 2019-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artemether-lumefantrine | Unknown | — | — |
| Subject | Primaquine | Small molecule | — | — |
| Subject | amodiaquine | Other / unclassified | — | — |
Indications
No indication recorded.