Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fulvestrant for Injectable Suspension
Fulvestrant for Injectable · 1 trial · 1 indication
Area under the concentration-time curve(AUC)
| Arm | Type | Description |
|---|---|---|
| Fulvestrant for Injectable Suspension | EXPERIMENTAL | Fulvestrant for Injectable Suspension (500 mg/vial) |
| Faslodex (R) | ACTIVE_COMPARATOR | Faslodex (250 mg/mL) |
| Name | Type | Description |
|---|---|---|
| Fulvestrant for Injectable Suspension | DRUG | Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area |
| Faslodex (Reference) | DRUG | Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas |
Inclusion Criteria: * Body Mass Index (BMI) of 18 kg/m2 to 32 kg/m2 * Body weight of at least 50 kg at screening * Good health as determined by evaluations * Negative serum pregnancy test * Subjects who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating horm...