A single dose two-phase crossover study to assess the tolerability and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets in healthy normal volunteers (Thailand)
| ISRCTN | ISRCTN22508774 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22508774 |
| Protocol serial number | RPC117 |
| Sponsor | Drugs for Neglected Diseases initiative (DNDi) (Switzerland) |
| Funders | Drugs for Neglected Diseases initiative (DNDi) (Switzerland), Confirming the International Role of Community Research for Development - Developing Countries (INCO-DEV), European Commission (ref: ICA4-2001-10193), 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) |
- Submission date
- 12/09/2005
- Registration date
- 01/02/2006
- Last edited
- 28/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| taylorw@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single dose two-phase crossover study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | A single dose two-phase crossover study to assess the tolerability and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets in healthy normal volunteers (Thailand) |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Received from the local medical ethics committee on 27/05/2005 |
| Health condition(s) or problem(s) studied | Pharmacokinetics of drug |
| Intervention | Two tablets of fixed dose artesunate and mefloquine, given once: total dose = AS 200mg, MQ 400 mg. Loose tablets - 200 mg of artesunate (4 tablets) and 500 mg of mefloquine (2 tablets). |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artesunate, mefloquine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 25/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Key inclusion criteria | 1. Age 18 to 50 years 2. Written consent given after reading the volunteer information leaflet. Participation must be voluntary and volunteers will be fully informed of possible side effects. They will be informed that they are free to withdraw at any time 3. No significant abnormal findings on history or examination, particularly no prior liver disease, cardiovascular disease (including arrythmias), peripheral neuropathy, convulsions, and psychiatric disease 4. No clinically significant abnormalities on: 4.1. Haematology: 4.1.1. Haemoglobin: male 13.6 - 17.5 g/dl, female 12 - 15.5 g/dl 4.1.2. Total white cell count: 4 - 10 x 10^3/ul 4.1.3. Platelet counts: 150 - 450 x 10^3/ul 4.2. Liver: 4.2.1. Total bilirubin less than 1.2 mg/dl 4.2.2. Serum Glutamic Oxaloacetic Transaminase (SGOT) less than or equal to 35 IU/l 4.2.3. Serum Glutamic Pyruvic Transaminase (SGPT) less than or equal to 35 IU/l 4.3. Renal function: 4.3.1. Creatinine 50 - 100 umol/l 4.3.2. Blood urea nitrogen 8 - 20 mg/dl 5. Negative pregnancy test (women) using the urine beta Human Chorionic Gonadotropin (βHCG) 6. Normal electrocardiogram (physicians reading: running at 50 mm/sec) 7. No history of antimalarial ingestion (chloroquine, amodiaquine, quinine, halofantrine, pyrimethamine-sulfadoxine) in the preceding two months, and for mefloquine, preceding three months 8. No other drugs or medications, including over-the counter preparations, ingested in the preceding week 9. Adequate venous access 10. Not participating in another clinical trial |
| Key exclusion criteria | 1. Refusal of consent 2. Clinically significant physical signs detected by the examining physician 3. Abnormal electrocardiogram detected by the examining physician 4. Presence of hepatic, renal and gastrointestinal disorders 5. Smokers (greater than 10 cigarettes/day), abuse of alcohol or recreational drugs 6. Presence of malaria parasites on a thick smear 7. Subjects having been in a malarial area in the preceding eight weeks 8. Subjects having ingested drugs in the preceding week 9. Presence of acute or chronic infections 10. Allergy to study drugs |
| Date of first enrolment | 25/02/2005 |
| Date of final enrolment | 25/02/2006 |
Locations
Countries of recruitment
- Switzerland
- Thailand
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/03/2017: Publication reference added.
