Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test drug · 1 trial · 1 indication
Area Under Curve(AUC) will be evaluated with Winnonlin analysis(Linear trapezoidal linear interpolation).
Plasma concentrations of fluconazole will be assayed by a validated LC- MS/MS method.
| Arm | Type | Description |
|---|---|---|
| Fluconazole 50 mg, Manufacturer: Amboise | EXPERIMENTAL | Test drug |
| Fluconazole 50mg, Manufacturer:West Ryde | ACTIVE_COMPARATOR | Reference drug |
| Name | Type | Description |
|---|---|---|
| Test drug | DRUG | Fluconazole capsule 50 mg Manufacturer: West Ryde |
| Reference drug | DRUG | Fluconazole capsule 50 mg Manufacturer: Amboise |
Inclusion Criteria * Healthy male and subjects who are between the ages of 19 and 55 years. * Female subjects who are found not to be pregnant in physical examinations * BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Evidence of a personally signed and dated informed consent...
Test drug is used for bioequivalence, meaning it is being studied to confirm that a manufactured version of the drug performs the same as a reference product. It is a small molecule being developed by Pfizer, Inc. for this purpose.
Pfizer, Inc. (NYSE: PFE) is developing Test drug. The company is conducting a clinical trial to support the transfer of the drug's manufacturing process, with the goal of demonstrating bioequivalence to the reference product.
Test drug is in Phase 1 clinical development. It is an investigational drug being studied for bioequivalence, and it is not yet approved by regulatory authorities. The Phase 1 trial has been completed.
Test drug has one completed clinical trial, NCT03821480, titled "Diflucan Bioequivalence Study For Transferring The Manufacture." This Phase 1 study enrolled 28 healthy volunteers in South Korea and was active-controlled, meaning it compared the test drug against an active reference.
Test drug is being studied for bioequivalence to Diflucan, as indicated by the clinical trial title. The trial aims to confirm that the manufactured Test drug matches Diflucan's performance, but Test drug itself is a distinct product under investigation.