drugset / Trial / NCT04080895
Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects
Phase 1
Terminated
8 enrolled
University of Oxford
Mahidol Oxford Tropical Medicine Research Unit · collabMahidol University · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This is an open-label pharmacokinetic study in 16 healthy Thai subjects. To assess the safety and tolerability and pharmacological interactions of the combination of artemether-lumefantrine and amodiaquine. This study is funded by Prof White's WT PRF. The Welcome Trust grant reference number is B9R04920.
Timeline
- Start
- 2022-11-01
- Primary completion
- 2025-04-01
- Completion
- 2025-04-01
Outcome
Outcome not reported
Stopped: “The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artemether-lumefantrine | Unknown | — | Oral |
| Subject | amodiaquine | Other / unclassified | — | Oral |
Indications
No indication recorded.