This is a single-dose, randomized, two-period cross-over study with 72 healthy male and female volunteers. The investigational products will be given (after fasting overnight) at separate visits separated by 7 ± 3 days. Blood for pharmacokinetic analyses will be drawn pre-dose and at 5, 10, 15, 20, 25, 30, 40, 60, 75, 90, 105 minutes, as well as 2, 2.25, 3, 4, 5, 6, 8, and 12 hours after drug administration. Subjects will also be monitored to capture any adverse events that may occur. Bioequivalence will be assessed based on the single-dose pharmacokinetics of paracetamol, guaifenesin and phenylephrine, respectively
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
72
Each subject will receive two tablets, each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride
Each subject will receive one sachet, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride
Scientific Research center Eco-Safety LLC
Saint Petersburg, Russia
Peak Plasma Concentration (Cmax) of paracetamol, guaifenesin and phenylephrine (total)
The maximum observed plasma concentration (Cmax)
Time frame: At baseline and during 12 hours after product administration
The area under the plasma concentration-vs.-time curves from start of drug administration until the time of the last measurable concentration (AUCt) for paracetamol, guaifenesin and phenylephrine (total)
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
Time frame: At baseline and during 12 hours after product administration
The area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) for paracetamol, guaifenesin and phenylephrine (total)
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the plasma concentration is negligible (infinity).
Time frame: At baseline and during 12 hours after product administration
The extrapolated part of AUC∞, AUCExtrap of paracetamol, guaifenesin and phenylephrine (total)
AUCextrap is defined as area under the plasma concentration versus time curves from 12 hours until infinity
Time frame: From 12 hours after start of drug administration until up to 96 hours
The time at which the maximum plasma concentration is observed (tmax) for paracetamol, guaifenesin and phenylephrine (total)
Tmax is defined as the time point at which the maximum plasma concentration (Cmax) occurs
Time frame: At baseline and during 12 hours after product administration
The half-life (t1/2) for paracetamol, guaifenesin and phenylephrine (total) in plasma
The half-life i defined as the time taken for the plasma concentration to fall to half its original value
Time frame: At baseline and during 12 hours after product administration
The terminal elimination rate constant (λz) for paracetamol, guaifenesin and phenylephrine (total) in plasma
The terminal elimination rate constant is the rate at which the drug is removed from the body system
Time frame: At baseline and during 12 hours after product administration
The mean residence time (MRT) for paracetamol, guaifenesin and phenylephrine (total)
Mean residence time (MRT) is the average amount of time that a single molecule of drug stays in the body
Time frame: At baseline and during 12 hours after product administration
Peak Plasma Concentration (Cmax) of unconjugated phenylephrine
The maximum observed plasma concentration (Cmax)
Time frame: At baseline and during 12 hours after product administration
The area under the plasma concentration-vs.-time curves from start of drug administration until the time of the last measurable concentration (AUCt) for unconjugated phenylephrine
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
Time frame: At baseline and during 12 hours after product administration
The area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) for unconjugated phenylephrine
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the plasma concentration is negligible (infinity).
Time frame: At baseline and during 12 hours after product administration
The extrapolated part of AUC∞, AUCExtrap of unconjugated phenylephrine
AUCextrap is defined as area under the plasma concentration versus time curves from 12 hours until the plasma concentration is negligible (infinity).
Time frame: From 12 hours after start of drug administration until up to 96 hours
The time at which the maximum plasma concentration is observed (tmax) for unconjugated phenylephrine
Tmax is defined as the time point at which the maximum plasma concentration (Cmax) occurs
Time frame: At baseline and during 12 hours after product administration
The half-life (t1/2) for unconjugated phenylephrine in plasma
The half-life i defined as the time taken for the plasma concentration to fall to half its original value
Time frame: At baseline and during 12 hours after product administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The terminal elimination rate constant (λz) for unconjugated phenylephrine in plasma
The terminal elimination rate constant is the rate at which the drug is removed from the body system
Time frame: At baseline and during 12 hours after product administration
The mean residence time (MRT) for unconjugated phenylephrine
Mean residence time (MRT) is the average amount of time that a single molecule of drug stays in the body
Time frame: At baseline and during 12 hours after product administration