Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01302093 | Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults | PHASE1 | COMPLETED | 40 | — | — | Jan 1, 2011 | Jan 1, 2011 | Jul 10, 2012 | 1 | Canada |
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)
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).
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
| 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 |
Inclusion Criteria: * Male or female subjects (equal numbers of males and females) * \- Volunteers aged of at least 18 years but not older than 55 years * \- Subjects will have a Body Mass Index (BMI) greater than or equal to 18.5 and below 30 kg/m2; and a total body weight \>50 kg * \- Non- or ex-...