Malaria vivax
Conditions
Interventions
group test 1 (n=30) Primaquine 15 mg single dose.
group test 2 (n=30) Primaquine 5 mg single dose.
group control (n=30) Primaquine 15 mg single dose (reference tablet).
Drug
Sponsors
Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Men, Non-pregnant and non-breastfeeding women Within the age range 18 to 50 years old Body Mass index range 19 to 28,5 Kg/m2 Health volunteers Signed Informed Consent
Exclusion criteria
Exclusion criteria: Hypersensibility to the drug (primaquine): Previous pathologies that could influence the absorption distribution or excretion of the drug; Positive G6PD deficiency quantitative or pregnancy test. Use o concomitant medicines; Any clinical or laboratory exam abnormality; Smokers; heavy coffee drinkers (>5 cups/Day); Abusive alcohol use: use of any treatment within 2 weeks before the study;Any previous hospitalization with 8 weeks before the study: Any previous treatment with known drug interaction with the test drug within 03 months; Blood donation greater than 450ml 03 months prior the study, or 1500ml in the previous 12 months; Use of Cyp 450 Inductors medications 4 weeks prior; Consume of alcohol or grapefruit 48h prior hospitalization;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the bioavailability in fastening conditions of a single dose administration of three primaquine formulations. Bioavailability will be accessed by the comparison of the pharmacokinetic parameters (AUC0-t, AUC0-inf, Ke, T½, Cmax, Tmax). The acceptance criteria are the estimated ratio of the geometric means of Cmax, AUC0-t of test and reference drugs and their 90% CI within the interval of 80-125%, | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events | — |
Countries
Brazil
Contacts
Public ContactDouglas Pinto
Fundação Oswaldo Cruz
Outcome results
None listed