Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fluconazole 150mg Capsule Originator
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...