This study evaluated the effect of food on the absorption of the drug as well as safety and tolerability in adults suffering from chronic Chagas' disease In addition pharmacokinetics of the drug following 120 and 240 mg single doses will be assessed
Primary objective was to evaluate the effect of various food compositions on the PK of nifurtimox after a single oral dose (120 mg) administered under 3 types of fed conditions (low fat, dairy products, and high calorie and high fat), as well as fasted conditions, to assess relative bioavailability. It was chosen to allow a direct inter-study comparison of PK data obtained in previous studies. A secondary objective of the study was to assess the relative bioavailability of 2 different dose levels of nifurtimox, given as a single oral dose, in a second group of patients.The second treatment group addressed a biopharmaceutical aspect for which no study data have been obtained to date. In order to assess the relationship between dose and exposure (linearity of PK), an analysis of the dose range of 120 mg to 240 mg was chosen to close the knowledge gap for this dose range.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Oral Intake of 4 x 30 mg nufurtimox tablets for treatment A-D; Oral Intake of 8 x 30 mg nufurtimox tablets for treatment E.
FP Clinical Pharma
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
AUC(0-tlast) of nifurtimox (evaluation of food effect)
Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point\[AUC(0-tlast)\]
Time frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
Cmax of nifurtimox (evaluation of food effect)
Peak concentrations (Cmax) of the plasma concentration vs time profiles
Time frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
Number of participants with treatment-emergent adverse events (TEAEs)
Clinical Laboratory Test, physical examinations, vital signs and 12 electrocardiograms ( ECG's) for safety and tolerability
Time frame: Up to 8 weeks
AUC(0-tlast)/D of nifurtimox (evaluation of food effect)
AUC(0-tlast)/D: AUC(0-tlast) divided by dose
Time frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
Cmax/D of nifurtimox (evaluation of food effect)
Cmax/D: Cmax divided by dose
Time frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
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