Malaria
Conditions
Keywords
healthy volunteers, pharmacokinetics, malaria, Argemone mexicana
Brief summary
The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.
Detailed description
This is an open non comparative safety and pharmacokinetic (PK) study clinical trial. Healthy volunteers aged from 18 to 50 years old will be recruited and followed 42 days after treatment initiation as in the current World Health Organization malaria drug protocol efficacy assessment protocol. Each volunteer will be take oral Argemone mexicana in decoction formulation. For the PK assessment purposes, 3 groups have been constituted: (i) a group will receive a unique dose of with blood withdrawal scheduled at 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hour , 8 hours and 12 hours. (ii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hours, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 3 days, 7 days and 14 days. (iii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hour, 12 hours, 14 hours, 16 hours, 18 hours, 20 hours, 22 hours, 24 hours, 3 days, 7 days, 14 days and 21 days Safety will be assessed clinically (Clinical exam and Electrocardiography) and biologically (hematology and biochemistry parameters will be measured) throughout the 42 days of thefollow-up.
Interventions
DRUGArgemone mexicana
30g, the powder decoction 2 times a day for 14 days
Sponsors
University of Geneva, Switzerland
University of Bamako
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* age of 18-50 years old; * be in good general health; * be available for the duration of the study; * agreement to participate in the study * be a resident of the village known study; * acceptance of the conservation laboratory specimens for future research.
Exclusion criteria
* Plasmodium falciparum infection with clinical manifestations; * Presence of severe or complicated malaria; * Acute medical condition; * Any other medical condition that requires medical attention inconsistent with the study or interfere with the study; * Severe medical conditions; * Allergy to the product of the study, * Pregnant women or nursing * Taking a derivative product of the study or other known antimalarial within 14 days before enrollment. * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 6 weeks | health volunteers will be assessed daily for 3 days and then on Day 7 and then weekly up to 6 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration curves of the drug | 6 weeks | The phramacokinetics measured will be performed depending on the treatment groups. Three different treatment groups have constituted, each group will be allocated a specific time point for PK assessment. |
Countries
Mali
Outcome results
None listed