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)
- Conditions
- Pharmacokinetics of drugNot Applicable
- Registration Number
- ISRCTN22508774
- Lead Sponsor
- Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration