Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CE/BZA · 1 trial · 1 indication
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
| Arm | Type | Description |
|---|---|---|
| Non-Obese | OTHER | BMI \<30 kg/m\^2 |
| Obese | OTHER | BMI \>= 30 kg/m\^2 |
| Name | Type | Description |
|---|---|---|
| CE/BZA | DRUG | CE 0.45mg/BZA 20mg tablets, single dose |
| Itraconazole | DRUG | Two 100 mg capsules, once daily for 7 days |
Inclusion Criteria: * Generally healthy postmenopausal women, aged 40-64. Intact Uterus Exclusion Criteria: * The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.
CE/BZA is a small molecule drug being developed by Pfizer, Inc. It is being studied in healthy postmenopausal women. The drug is currently in Phase 1 clinical development, and it is investigational, meaning it has not been approved for any use.
CE/BZA is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.
CE/BZA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
CE/BZA has one completed Phase 1 clinical trial, NCT02100553. This study evaluated the effects of multiple-dose administration of itraconazole on the single-dose pharmacokinetics of conjugated estrogens/bazedoxifene in non-obese and obese postmenopausal women.
CE/BZA is a name for the combination of conjugated estrogens and bazedoxifene. The clinical trial NCT02100553 refers to the drug as conjugated estrogens/bazedoxifene, indicating that CE/BZA is an abbreviation for this combination.