Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Racecadotril Film-Coated Tablet (FCT)
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 oral small molecule developed for the treatment of diarrhea in adults. It is studied as an antidiarrheal agent, and the film-coated tablet form has been evaluated in a bioequivalence study comparing it with a racecadotril capsule in healthy adult volunteers.
Racecadotril Film-Coated works as an inhibitor of MME, also known as neprilysin. By inhibiting this enzyme, the drug reduces the breakdown of endogenous opioid peptides, which decreases intestinal hypersecretion and produces an antidiarrheal effect without slowing intestinal transit.
Racecadotril Film-Coated is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor behind the clinical evaluation of this film-coated tablet formulation of racecadotril.
Racecadotril Film-Coated is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The single Phase 1 trial of this formulation has been completed, and no trials are currently active.
Racecadotril Film-Coated has been studied in one completed Phase 1 trial, NCT01302093, titled Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults. The trial enrolled 40 healthy adult volunteers in Canada and used an active-controlled, randomized design.
Yes, Racecadotril Film-Coated and Racecadotril Film-Coated Tablet (FCT) refer to the same product. FCT is simply the abbreviated name for the film-coated tablet formulation of racecadotril, the oral dosage form evaluated in the Phase 1 bioequivalence study.