Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vicks Active SymptoMax Plus for · 1 trial · 2 indications
The maximum observed plasma concentration (Cmax)
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the plasma concentration is negligible (infinity).
AUCextrap is defined as area under the plasma concentration versus time curves from 12 hours until infinity
Tmax is defined as the time point at which the maximum plasma concentration (Cmax) occurs
The half-life i defined as the time taken for the plasma concentration to fall to half its original value
The terminal elimination rate constant is the rate at which the drug is removed from the body system
Mean residence time (MRT) is the average amount of time that a single molecule of drug stays in the body
| Arm | Type | Description |
|---|---|---|
| Treatment sequence AB | EXPERIMENTAL | Treatment A (experimental): Two tablets of Combination tablet with paracetamol, guaifenesin and phenylephrine hydrochloride each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride Treatment B (active comparator): One sachet Vicks Active SymptoMax Plus, powder for oral solution, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride |
| Treatment sequence BA | EXPERIMENTAL | Treatment A (experimental): Two tablets of Combination tablet with paracetamol, guaifenesin and phenylephrine hydrochloride each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride Treatment B (active comparator): One sachet Vicks Active SymptoMax Plus, powder for oral solution, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride |
| Name | Type | Description |
|---|---|---|
| Tablet paracetamol, guaifenesin and phenylephrine HCL | DRUG | Each subject will receive two tablets, each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride |
| Vicks Active SymptoMax Plus powder for oral solution | DRUG | Each subject will receive one sachet, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride |
Inclusion Criteria: 1. Subjects being verified as "Healthy": "Healthy" is defined as absence of any diseases or abnormalities on the basis of physical examination, standard clinical laboratory, and instrumental examinations performed at the screening visit. 2. Females of childbearing potential must...