The objective of the study is to compare the bioequivalence of a New Paracetamol Oral Suspension 24 milligram/milliliter (mg/ml) with that of an already approved Paracetamol (24 mg/ml) Oral Suspension (Panadol Baby \& Infant) when administered to healthy volunteers under fasting condition. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.
This will be a 2-arm, single center, single dose, open-label, randomized, two-sequence, two period crossover, bioequivalence study in healthy adult participants. Participants will be screened for eligibility within 15 days prior to dosing. Participants will receive each of the two study treatments in fasted state during a 6-day (5-overnight stay) residential period at the study site. Participants will receive both treatment regimens in a randomized order with a 72-hour washout period between each dose. During each treatment period, a total of 21 blood samples will be collected which will include a pre-dose blood sample 1 hour before dosing and 20 post-dose blood samples at 5, 10, 20, 30, 40, 50, 60, 80, 90, 120, 150, 180 minutes, 4, 5, 6, 8, 10, 12, 14, 16 hours, for bioanalytical analyses of paracetamol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
61
After an overnight fasting for at least 10 hours, New Paracetamol Oral Suspension (24 mg/ml) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.
After an overnight fasting for at least 10 hours, Panadol B\&I Oral Suspension (24 mg/ml paracetamol) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.
GSK Investigational Site
Prague, Czechia
The Area Under the Plasma Concentration [AUC] Versus Time Curve Calculated From Time Zero to the Last Measurable Sampling Time Point (Tlast) (AUC [0-tlast])
Blood samples were collected at the indicated time points for the analysis of AUC (0-tlast). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
The Time of the Maximum Observed Post-dose Concentration (Tmax)
Blood samples were collected at the indicated time points for for the analysis of tmax. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
The Maximum Observed Post-dose Concentration (Cmax)
Blood samples were collected at the indicated time points for for the analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)]
AUC (0-inf) = AUC (0-tlast) + Clast/ λz, where Clast is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Blood samples were collected at the indicated time points for for the analysis of AUC (0-inf). PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex)
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%AUCex = (1- \[AUC0-tlast/AUC0-inf\]\*100). Blood samples were collected at the indicated time points for for the analysis of %AUCex. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Terminal Elimination Rate Constant (λz)
λz is computed as the slope of the regression line of ln (concentration) verses time. Blood samples were collected at the indicated time points for for the analysis of λz. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post Dose.