Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vicks Active SymptoMax Plus · 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...
Vicks Active SymptoMax Plus is a small molecule product developed by Johnson & Johnson for cough and cold symptoms. It is also known as Vicks Active SymptoMax Plus powder for oral solution. The specific indications have not been disclosed. It has been studied in a Phase 1 bioequivalence trial in healthy volunteers.
Vicks Active SymptoMax Plus is developed by Johnson & Johnson, which trades under the ticker JNJ. The product is also known as Vicks Active SymptoMax Plus powder for oral solution. Johnson & Johnson is the company responsible for its development.
Vicks Active SymptoMax Plus is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA.
Vicks Active SymptoMax Plus has been evaluated in one completed Phase 1 trial, NCT03213353, titled A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms. The trial enrolled 72 healthy volunteers in Russia and was randomized and controlled, though not double-blind.