Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femulen commercial tablets | Active Comparator |
| |
| Femulen reformulated tablets | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etynodiol diacetate | Drug | tablet, 0.5 mg, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve to last time point observed (AUCt) | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | |
| Highest concentration (Cmax) | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve to infinity (AUCinf) | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | |
| Area under the curve percent to infinity (AUC%inf) | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| etynodiol diacetate |
| Drug |
tablet, 0.5 mg, single dose |
|
| Half-life (T1/2) |
| 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 |
| Time at maximum concentration (Tmax) | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 |
| ID | Term |
|---|---|
| D005040 | Ethynodiol Diacetate |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided