A single-dose, open-label, single-treatment, single-period pharmacokinetic study under fasting conditions, in 12 healthy adult. To evaluate the single dose pharmacokinetic profile ANAWIDOW \[antivenin latrodectus (black widow) equine immune F(ab´)2\] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use.
To evaluate the single dose pharmacokinetic profile ANAWIDOW \[antivenin latrodectus (black widow) equine immune F(ab´)2\] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use of Laboratorios Silanes, S.A. de C.V. in healthy adult human male and female subjects under fasting conditions. To assess the safety of single dose of ANAWIDOW \[antivenin latrodectus (black widow) equine immune F(ab´)2\] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use in healthy adult human male and female subjects under fasting conditions. In a minimum of 12 healthy adult. In this study, all subjects will be required to fast overnight for at least 10.00 hours prior to dosing at least 04.00 hours post-dose. In this study, 3 ANAWIDOW 10 mL vials (3x10 mL) will be administered after diluting with normal saline solution up to 50 mL as intravenous infusion over 30 minutes. The solution will be infused through a 20-gauge catheter placed in the subject's left or right hand antecubital fossa at room temperature under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Antivenin latrodectus (black widow) equine immune F(ab)2\] lyophilized powder for solution 10 mL for intravenous use \[parenteral formulation\]; hence, a single-dose fasting pharmacokinetic study is planned.
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, Mexico
Maximum observed concentration following the treatment (Cmax).
To evaluate the single dose pharmacokinetic profile ANAWIDOW \[antivenin latrodectus (black widow) equine immune F(ab´)2\] lyophilized powder for solution 10 mL, employing the maximum observed concentration following the treatment (Cmax).
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal linear-interpolation method.
To evaluate the single dose pharmacokinetic profile ANAWIDOW \[antivenin latrodectus (black widow) equine immune F(ab´)2\] lyophilized powder for solution 10 mL, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal linear-interpolation method.
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The area under the curve from time zero to infinity calculated (AUC 0-inf).
The area under the curve from time zero to infinity calculated (AUC 0-inf). Where AUC0-inf = AUC0-t + Ct/ λz, Ct is the last measurable concentration, and λz is the terminal elimination rate constant.
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
Time of the maximum measured concentration (Tmax).
To evaluate the single dose pharmacokinetic profile ANAWIDOW \[antivenin latrodectus (black widow) equine immune F(ab´)2\] lyophilized powder for solution 10 mL, employing the time of the maximum measured concentration (Tmax).
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
First order rate constant associated with the terminal portion of the curve (log-lineal), Lambda_z (Kel).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
This is estimated via linear regression of time vs log concentration data. This parameter will be calculated using at least three or more non-zero serum concentration values.
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The elimination half-life (HL_Lambda_z (t½))
The elimination half-life will be calculated as 0.693/ λz.
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
Vd (Volume of distribution)
A(t) (mg) / C(t) (mg/L) \[A(t) represents the amount of drug in the body at time = t \& C(t) represents serum / plasma concentration of the drug at time = t\]
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
Clearance (CL)
CL (body) = Kel x Vd (volume/hour)
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
Physical examination
Physical examination will be performed before check-in of study period and may also be performed at any time during the study conduct if judged necessary by the physician.
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Sitting blood pressure (mmHg)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Pulse rate (p/m)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Respiratory rate (rr)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Axillary-body temperature (°C)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Hematology & biochemistry laboratory tests
Hematology \& biochemistry laboratory tests will be performed at the end of the study for all the subjects who administered with the study drug
Time frame: 21 days
Medical examination
It will be performed before check -in, prior to the dosing and before the check-out. Nevertheless, it may also be performed at any time during the study conduct if judged necessary by the physician.
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days