Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18 mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose, three-period crossover trial in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
Primary endpoint evaluated will be the PK parameters that define bioavailability in extent Ln [AUC0t]
For group 3
Time frame: up to day 7
Primary endpoint evaluated will be the PK parameters that define bioavailability in extent in rate: Ln [Cmax] for each treatment in healthy volunteers with high weight (Group 3), calculated by means of a non-compartmental analysis.
For group 3
Time frame: up to day 7
Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent Ln [AUC0t]
for group 1 and 2
Time frame: up to day 7
Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent in rate: Ln [Cmax]
for group 1 and 2
Time frame: up to day 7
AUC0t (for non-compartmental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
AUC0∞ (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
%AUC extra (residual area) (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
tmax (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
tlag (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
Cl/F (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
V/F (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
t1/2 (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
Ke (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
MRT (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
Cmax (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
tlag (for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
ka (for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: D7
Cl/F(for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
V/F (for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Time frame: up to day 7
vital signs
To asses safety and tolerability of the treatments
Time frame: up to week 6
laboratory analysis
To asses safety and tolerability of the treatments
Time frame: up to week 6
Incidence of adverse events.
To asses safety and tolerability of the treatments
Time frame: up to week 6
ECG
To asses safety and tolerability of the treatments
Time frame: up to week 6
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