Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and in adults when compared to Children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
Area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC 0-t + C last/kel, where C last is the last measurable concentration and kel is the apparent first-order terminal elimination rate constant.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Percent of AUC 0-inf Extrapolated (AUC%Extrapolated)
Percent of AUC 0-inf extrapolated, calculated as (1 - AUC 0-t / AUC 0-inf) x 100.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Apparent First-order Terminal Elimination Half-life (t½)
Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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Apparent First-order Terminal Elimination Rate Constant (Kel)
Apparent first-order terminal elimination rate constant calculated from a semilog plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., three or more non-zero plasma concentrations) in the terminal log-linear phase.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Number of Adverse Events (AEs) of Participants
Intensity determination: Mild=AE does not limit usual activities;subject may experience slight discomfort; Moderate= AE results in some limitation of usual activities; subject may experience significant discomfort; Severe=AE results in an inability to carry out usual activities; subject may experience intolerable discomfort or pain; Unlikely=Slight but remote chance that the AE was caused by study drug but the balance of judgment is that it was most likely not due to the study drug Possible=Reasonable suspicion that the AE was caused by the study drug; Probable=Most likely that the AE was caused by study drug.
Time frame: Upto Day 1