Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluconazole · 1 trial · 1 indication
Concentration maximum
Area under the plasma concentration time curve from time 0 to the last data point above the lower limit of quantification
| Arm | Type | Description |
|---|---|---|
| Fluconazole, period 1 | EXPERIMENTAL | Subjects were randomized to receive a single dose of 150 mg fluconazole on Day 1 of period 1 after an overnight fast of at least 10 hours |
| Fluconazole, period 2 | EXPERIMENTAL | Subjects were randomized to receive a single dose of 150 mg fluconazole on Day 1 of period 2 after an overnight fast of at least 10 hours |
| Name | Type | Description |
|---|---|---|
| Fluconazole (BAYT006267) 150 mg capsules | DRUG | Fluconazole 150 mg |
| Fluconazole 150 mg capsules (DiflucanTM) | DRUG | Fluconazole 150 mg |
Inclusion Criteria: * Healthy males in the age between 18 and 50 years * Subjects with a body weight of at least 50 kg and a BMI between 18.5 and 30.0 kg/m2 * Subjects had to be willing to use an acceptable method of contraception (double barrier) during the study and 2 weeks after the end of the s...