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ISRCTN
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ISRCTN70132716
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ClinicalTrials.gov identifier
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Public title
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Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination (Malaysia)
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Scientific title
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Acronym
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N/A
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Serial number at source
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RPC112
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Malaysia
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Disease/condition/study domain
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Malaria
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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26/11/2004
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Anticipated end date
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26/11/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Artesunate tablet 50 mg. Amodiaquine tablet (153 mg base/tablet).
Combination of artesunate/amodiaquine (100 mg and 270 mg, respectively).
For both arms, a single dose of appropriate drug(s) will be taken orally with 200 ml tap water after an overnight fast.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
2. European Commission
3. United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
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Trial website
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Publications
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Contact name
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Dr
W
Taylor
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Address
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20, Avenue Appia
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City/town
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Geneva -27
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Zip/Postcode
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CH 1211
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Country
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Switzerland
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Email
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taylorw@who.int
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Sponsor
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Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
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Address
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15 Chemin Louis Dunant
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City/town
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Geneva
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Zip/Postcode
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CH-1202
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Country
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Switzerland
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Tel
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+41 (0)22 906 9230
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Fax
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+41 (0)22 906 9231
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Email
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dndi@dndi.org
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Sponsor website:
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http://www.dndi.org
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Date applied
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15/04/2005
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Last edited
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24/11/2008
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Date ISRCTN assigned
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07/06/2005
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