This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition.
This will be a randomized, open-label, single-center, single-dose, two-treatment, two-period, two sequence crossover bioequivalence study in healthy adult participants with at least a 7-day washout period between treatment administrations. A sufficient number of participants were screened to randomize approximately 60 participants, Participants were randomly assigned to one of the two treatment sequences and receive a single dose of each treatments in each (of 2) periods following a crossover design. Blood was sampled regularly at scheduled times for 48 hours following treatment in each period to assess the pharmacokinetic parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
(Sacubitril/Valsartan) 24 mg/26 mg tablet of SAMI Pharmaceuticals (Pvt) Ltd
Entresto® (Sacubitril/Valsartan) 24 mg/26 mg tablet of Novartis Pharmaceuticals Ltd
Center for Bioequivalence Studies and Clinical Research (CBSCR) , ICCBS, University of Karachi
Karachi, Sindh, Pakistan
AUC
Area under the plasma drug concentration time curve
Time frame: 0-48 hours post dose
Cmax
Maximum Plasma Concentration
Time frame: 0 - 48 hours post dose
Tmax,
Time required for maximum plasma drug concentration,
Time frame: 0-48 hours post dose
t1/2
Half Life.
Time frame: 0-48 hours post dose
Blood Pressure
monitoring of blood pressure both systolic pressure and diastolic pressure, after dose administration
Time frame: 0-48 hours post dose
Body temperature
post dose body temperature measurement
Time frame: 0-48 hours post dose
Heart rate.
Measurement of heart rate after dosing..
Time frame: 0-48 hours post dose
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