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This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.
The study is a single dose, randomized, three-way crossover study in 30 healthy subjects, with equal numbers of males and females (minimum of 13 of either gender). Drop-outs will not be replaced. The three doses of medication given in the study (a single dose in each of the three study periods) will each be separated by a washout period of at least 7 calendar days. In each study period, eighteen (18) blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of ibuprofen (R-enantiomer and S-enantiomer) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data [R-enantiomer, S-enantiomer and total (sum of both enantiomers)]. The rate and extent of absorption of the formulations will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental Ibuprofen |
|
| Nurofen | Active Comparator | Nurofen Meltlets Orodispersible Tablet |
|
| Motrin | Active Comparator | Junior Strength Motrin Chewable Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | A single 2 x 100 mg dose of an experimental Ibuprofen Fast Melt Orodispersible Tablet administered orally, with a 7-day washout 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 12 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 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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-∞). |
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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 |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Ibuprofen | Drug | A single 200 mg Nurofen Meltlets Orodispersible Tablet administered orally, with a 7-day washout between visits |
|
|
| Ibuprofen | Drug | A single 2 x 100 mg dose of Junior Strength Motrin Chewable Tablet administered orally, with a 7-day washout between visits |
|
|
| 12 hours post-dose |
| Time of Maximum Concentration | The time at which maximum concentration is reached (Tmax) | During 12 hours post-dose |
| Terminal Elimination Rate Constant | The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose | During 12 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 12 hours post-dose |