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
Secondary identifying numbers	RPC112

Submission date: 15/04/2005
Registration date: 07/06/2005
Last edited: 28/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr W Taylor
Scientific

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Email	taylorw@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Artesunate, amodiaquine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	26/11/2004
Completion date	26/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target number of participants	Not provided at time of registration
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

Locations

Countries of recruitment

Malaysia
Switzerland

Study participating centre

20, Avenue Appia

Geneva -27
CH 1211
Switzerland

Sponsor information

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Research organisation

15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland

Phone	+41 (0)22 906 9230
Email	dndi@dndi.org
Website	http://www.dndi.org
"ROR"	https://ror.org/022mz6y25

Funders

Funder type

Research organisation

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

No information available

European Commission
Government organisation / National government

Alternative name(s): European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, EC, EU

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

28/03/2017: Publication reference added.