Malaria
Conditions
Brief summary
* Primary Objective: to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male subjects * Secondary Objective: to assess the clinical and biological safety and tolerability of Coarsucam™
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Caucasian subjects * Weight between 50 kg and 90 kg. 18 ≤ Body Mass Index ≤ 28 kg/m2. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics/Time course of the plasma concentrations of AS, AQ & their pharmacologically active metabolites dihydroartemisinin (DHA) & desethylamodiaquine (DSA), used to determine:Tmax, Cmax, t1/2, AUC(0-t) & AUC(0-Inf) for AS, DHA & AQ | During all the study conduct |
| Tmax, Cmax, Truncated AUC(0-10d) for DSA | during the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters. | From the signature of the informed consent up to the end of the study |
Countries
France
Outcome results
None listed