A study of the plasma concentration-time profile and antimalarial activity of plasma samples collected from healthy Vietnamese volunteers after the administration of artesunate-amodiaquine alone and with methylene blue.

Phase 1

• Conditions: Malaria; Antimalarial drug resistance; Infection - Other infectious diseases

• Registration Number: ACTRN12612001298808
• Lead Sponsor: Australian Army Malaria Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

(i) Males: 17-40 years
(ii) Normal clinical parameters: medical history, physical examination
(iii) Normal haematological and biochemical indices, and electrocardiogram
(iv) Normal glucose-6-phosphate dehydrogenase (G6PD)
(v) Able to understand and willing to provide written informed consent

Exclusion Criteria

(i) A history of serious past medical diseases
(ii) A history of drug or alcohol abuse
(iii) Use of regular medications including prescribed and natural therapies
(iv) Use of serotonergic psychiatric medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified