Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Racecadotril Film-Coated · 1 trial · 1 indication
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-...
Racecadotril Film-Coated is an investigational small molecule being developed as an antidiarrheal agent. It is intended for the treatment of diarrhea in adults. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Racecadotril Film-Coated is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development as an antidiarrheal treatment.
Racecadotril Film-Coated is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed, and the drug remains under clinical investigation.
Racecadotril Film-Coated has one completed clinical trial, NCT01302093, which was a Phase 1 bioequivalence study comparing a racecadotril capsule and film-coated tablet for treating diarrhea in adults. The trial enrolled 40 participants in Canada and included healthy volunteers.
Racecadotril Film-Coated is a film-coated tablet formulation of the drug racecadotril. The completed clinical trial NCT01302093 was designed to assess bioequivalence between a racecadotril capsule and the film-coated tablet formulation.