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
Not provided at time of registration
Contact information
Dr W Taylor
Scientific
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| taylorw@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | 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 |
| Overall study end date | 26/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 26/11/2004 |
| Recruitment end date | 26/11/2006 |
Locations
Countries of recruitment
- Malaysia
- Switzerland
Study participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Research organisation
Research organisation
15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland
| Phone | +41 (0)22 906 9230 |
|---|---|
| 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
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, 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 | Not provided at time of registration |
| 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.
