Pharmacokinetics of drug Not Applicable
Conditions
Interventions
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).
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
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 (ßHCG) 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Thailand
Outcome results
None listed