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| ID | Type | Description | Link |
|---|---|---|---|
| 3117X3-1112 |
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The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Premarin reference tablet as a single oral dose under fasted conditions |
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| B | Experimental | Premarin new tablet as a single oral dose under fasted conditions |
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| C | Experimental | Premarin reference tablet as a single oral dose under fed conditions |
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| D | Experimental | Premarin new tablet as a single oral dose under fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Premarin reference tablet (fasted) | Drug | Premarin reference tablet, single dose, fasted conditions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax | Day 1 to Day 4 | |
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall | Day 1 to Day 4 | |
| Plasma unconjugated equilin pharmacokinetic parameter:Cmax | Day 1 to Day 4 | |
| Plasma unconjugated equilin pharmacokinetic parameter:AUCall | Day 1 to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax | Day 1 to Day 4 | |
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast | Day 1 to Day 4 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Shinjyuku-ku | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Premarin new tablet (fasted) |
| Drug |
Premarin new tablet, single dose, fasted conditions |
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| Premarin reference tablet (fed) | Drug | Premarin reference tablet, single dose, fed conditions |
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| Premarin new tablet (fed) | Drug | Premarin new tablet, single dose, fed conditions |
|
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf |
| Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT | Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life | Day 1 to Day 4 |
| Plasma unconjugated equilin pharmacokinetic parameter:Tmax | Day 1 to Day 4 |
| Plasma unconjugated equilin pharmacokinetic parameter:AUClast | Day 1 to Day 4 |
| Plasma unconjugated equilin pharmacokinetic parameter:AUCinf | Day 1 to Day 4 |
| Plasma unconjugated equilin pharmacokinetic parameter:MRT | Day 1 to Day 4 |
| Plasma unconjugated equilin pharmacokinetic parameter:half-life | Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life | Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax | Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax | Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast | Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall | Day 1 to Day 4 |
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT | Day 1 to Day 4 |
| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| D014627 | Vaginitis |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D014623 | Vaginal Diseases |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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