Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluconazole Originator · 1 trial · 1 indication
Area under the plasma concentration-time profile from time zero to 72 hours post dose based on observed plasma concentrations at time points 0 (prior-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose using linear/log trapezoidal methods
Maximum plasma concentration among observed plasma concentrations at time points 0 (prior-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose
| Arm | Type | Description |
|---|---|---|
| Reference | OTHER | Fluconazole 150mg Capsule Originator |
| Experimental | EXPERIMENTAL | Fluconazole 150mg Capsule Localized Originator |
| Name | Type | Description |
|---|---|---|
| Fluconazole 150mg Capsule Originator | DRUG | 150mg fluconazole capsule (originator) manufactured at Pfizer Fareva, Amboise, France |
| Fluconazole 150mg Capsule Localized Originator | DRUG | 150mg Fluconazole capsule (localized originator) manufactured at Pfizer, Dalian, China |
Inclusion Criteria: 1. Healthy Chinese male and female subjects, between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurem...
Fluconazole Originator is the original formulation of fluconazole, an antifungal small molecule developed by Pfizer, Inc. (NYSE: PFE). It is also known as Fluconazole 150mg Capsule Originator. The product has been studied in a Phase 1 bioequivalence trial comparing capsules manufactured in China and France.
Fluconazole Originator is made by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the developer of the originator fluconazole product.
Fluconazole Originator has been evaluated in a Phase 1 clinical trial. That trial, NCT03621072, is completed. The program is not currently listed with any active trials.
Fluconazole Originator has been studied in one completed clinical trial, NCT03621072, titled "Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France." The trial enrolled 36 healthy adult volunteers in China and was randomized and controlled.