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

ISRCTN	ISRCTN70132716
DOI	https://doi.org/10.1186/ISRCTN70132716
Protocol serial number	RPC112
Sponsor	Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Funders	Drugs for Neglected Diseases initiative (DNDi) (Switzerland), European Commission, 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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr W Taylor
Scientific

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Email	taylorw@who.int

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination (Malaysia)
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Malaria
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Artesunate, amodiaquine
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	26/11/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Key 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
Key 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
Date of first enrolment	26/11/2004
Date of final enrolment	26/11/2006

20, Avenue Appia

Geneva -27
CH 1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

28/03/2017: Publication reference added.