Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination (Malaysia)

Not Applicable

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN70132716
• Lead Sponsor: Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-07
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Male/female age 21 - 45 years
2. Written consent
3. Voluntary participation fully aware of possible side effects
4. No significant abnormal findings on history or examination, particularly no prior liver disease, cardiovascular disease or peripheral neuropathy
5. No clinically significant abnormalities on haematology, liver and renal function tests
6. Non pregnant on test (women)
7. Normal electrocardiogram (ECG)
8. No history of antimalarial ingestion (chloroquine, amodiaquine, quinine, halofantrine, pyrimethamine-sulfadoxine associated or not to mefloquine) in the preceding two months
9. No other drugs or medications, including over-the-counter preparations, ingested in the preceding week
10. Adequate venous access

Exclusion Criteria

1. Refusal of consent
2. Biological or electrocardiographic anomalies
3. Presence of hepatic, renal and gastrointestinal disorders
4. Smokers (>10/day), abuse of alcohol or recreational drugs
5. Presence of malaria parasites on a thick smear
6. Subjects having been in a malarial area in the preceding 8 weeks
7. Subjects having ingested drugs in the preceding week
8. Presence of acute or chronic infections

Study & Design

• Study Type: Interventional
• Study Design: Not specified