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This study is designed to assess bioequivalence between two products used for treatment of allergy.
This study is designed to evaluate if a test formulation of cetirizine 10 mg orodispersible tablet (ODT) taken with and without water is bioequivalent to a marketed reference formulation of cetirizine 10 mg tablet (Benadryl One A Day, McNeil Products Ltd, UK) taken with water. This study will also evaluate the tolerability of test and reference formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODT with Water | Experimental | Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water |
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| ODT Without Water | Experimental | Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water |
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| FCT with Water | Active Comparator | Marketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetirizine | Drug | A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration | Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL) | During 32 hours post-dose |
| Bioavailability [AUC(0-t)] | Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL). | During 32 hours post-dose |
| Bioavailability Extrapolated to Infinity [AUC (0-∞)] | Bioavailability Extrapolated to Infinity [AUC (0-∞)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-∞) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-∞). | 32 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Concentration | The time at which maximum concentration is reached (Tmax) | During 32 hours post-dose |
| Terminal Elimination Rate Constant | The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose |
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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 |
|---|---|---|---|---|---|---|
| Algorithme Pharma Inc. | Mount Royal | Quebec | H3P 3P1 | Canada |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Cetirizine | Drug | A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits |
|
|
| During 32 hours post-dose |
| Terminal Phase Plasma Half-Life | Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose. | During 32 hours post-dose |
| Area under the Curve to the Tmax of the Reference Products | Area under the plasma concentration versus time curve to the time of the maximum concentration of the reference products (AUCReftmax) | During 32 hours post-dose |
| Relative percentage of AUCT with respect to AUC∞ (AUCT/∞) | AUCT is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration. AUC∞ is the area under the plasma concentration versus time curve from start of drug administration until extrapolated infinite time. AUCT/ AUC∞ is an inversed measure of how large the extrapolated area under the curve is. | During 32 hours post-dose |
| Mean Residence Time | The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system. | During 32 hours post-dose |