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Also known as Premarin, Premarin® oral tablets
Premarin reference · 5 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Premarin reference tablet as a single oral dose under fasted conditions |
| B | EXPERIMENTAL | Premarin new tablet as a single oral dose under fasted conditions |
| C | EXPERIMENTAL | Premarin reference tablet as a single oral dose under fed conditions |
| D | EXPERIMENTAL | Premarin new tablet as a single oral dose under fed conditions |
| 1 | OTHER | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Premarin reference tablet (fasted) | DRUG | Premarin reference tablet, single dose, fasted conditions |
| Premarin new tablet (fasted) | DRUG | Premarin new tablet, single dose, fasted conditions |
| Premarin reference tablet (fed) | DRUG | Premarin reference tablet, single dose, fed conditions |
| Premarin new tablet (fed) | DRUG | Premarin new tablet, single dose, fed conditions |
| Premarin | DRUG | - |
| Premarin®/MPA formulation A | DRUG | - |
| Premarin®/MPA formulation B | DRUG | - |
| Premarin®/MPA formulation C | DRUG | - |
| Premarin®/MPA currently marketed product | DRUG | - |
| Premarin/MPA | DRUG | 0.625 mg/2.5 mg X4 |
| Provera 10 mg | DRUG | 2.5 mg of MPA, 4 tablets dissoved in water |
| Premarin/MPA 0.45 mg/1.5 mg | DRUG | - |
Inclusion Criteria: * Japanese healthy postmenopausal women Exclusion Criteria: * History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies. * History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malign...
Premarin is a conjugated estrogens product studied in menopausal and postmenopausal women, as well as in primary ovarian insufficiency. Its clinical program has evaluated oral tablet formulations in these endocrine-related conditions, including work in Japanese healthy postmenopausal women and in studies of hormone absorption and drug interaction.
Premarin is developed and manufactured by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor behind the clinical studies of Premarin and Premarin/MPA formulations referenced in the drug's development record.
Premarin is in Phase 1 clinical development. All three completed trials in its program are Phase 1 studies, and there are currently no active trials. The studies enrolled a total of 76 participants and were conducted in healthy volunteers, primarily postmenopausal women.
Premarin has been studied in completed Phase 1 trials including NCT01436513, which compared absorption of Premarin components in Japanese healthy postmenopausal women under fasted and fed conditions, NCT00745173, which evaluated a potential interaction between Premarin and bazedoxifene, and NCT00630435, which compared new Premarin/MPA formulations with a reference formulation.
Premarin trials were randomized and active-controlled, though not double-blind, and enrolled healthy female volunteers. Studies included comparisons of different Premarin tablet formulations, assessment of Premarin and bazedoxifene interaction, and comparisons of Premarin/MPA with PREMPRO and Provera in healthy postmenopausal women.