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This study is designed to assess bioequivalence between two products used for treatment of acute diarrhea.
The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females (minimum of 18 of either gender). Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 calendar days. In each study period, twenty (20) blood samples for pharmacokinetic analysis and, for the first 8 male and 8 female subjects included in the study (total of 16 subjects), seven (7) blood samples for pharmacodynamic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of thiorphan in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Tablet | Experimental | A single 100 mg dose of an experimental Racecadotril Film-Coated Tablet (FCT) |
|
| Marketed Capsule | Active Comparator | A single 100 mg dose of a marketed Racecadotril capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Racecadotril Film-Coated Tablet (FCT) | Drug | A single 100 mg dose of an experimental Racecadotril FCT administered orally with 240 ml of water, 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 24 hours following drug administration |
| 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 24 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 |
|---|---|
| C049331 | racecadotril |
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| Racecadotril Capsule | Drug | A single 100 mg dose of a marketed Racecadotril capsule administered orally with 240 ml of water, with a 7-day washout between visits |
|
|
| 24 hours post-dose |
| Time of Maximum Concentration | The time at which maximum concentration is reached (Tmax) | During 24 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 24 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 24 hours post-dose |