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Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects

NCT04080895 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Pharmacokinetic
  • Healthy
  • Drug Combination

Interventions

DRUG

Artemether-lumefantrine

Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks

DRUG

Amodiaquine

Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks

DRUG

Artemether-lumefantrine

Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks

DRUG

Artemether-lumefantrine + Amodiaquine

Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

  • Mahidol University

    collaborator OTHER

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080895 on ClinicalTrials.gov