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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of paracetamol, guaifenesin and phenylephrine (total) | The maximum observed plasma concentration (Cmax) | 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. | 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). | 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 | 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 | At baseline and during 12 hours after product administration |
| The half-life (t1/2) for paracetamol, guaifenesin and phenylephrine (total) in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of unconjugated phenylephrine | The maximum observed plasma concentration (Cmax) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kruse, PhD | McNeil AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Research center Eco-Safety LLC | Saint Petersburg | 196143 | Russia |
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| Label | URL |
|---|---|
| Redacted Study Synopsis | View source |
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|
| 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 |
|
The half-life i defined as the time taken for the plasma concentration to fall to half its original value |
| 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 | 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 | At baseline and during 12 hours after product administration |
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration. |
| 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). | 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). | 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 | 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 | At baseline and during 12 hours after product administration |
| 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 | 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 | At baseline and during 12 hours after product administration |
| ID | Term |
|---|---|
| D006140 | Guaifenesin |
| D010109 | Oxymetazoline |
| D011208 | Powders |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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