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The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers
The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg) |
|
| B | Other | After a single administration of PT105 (leuprorelin acetate 3.75mg), a single administration of PT105R (leuprorelin acetate 3.75mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leuprorelin acetate 3.75mg | Drug | PT105, PT105R |
|
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| Measure | Description | Time Frame |
|---|---|---|
| AUC7-t of Leuprolide | AUC7-t | 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr |
| AUCt of Leuprolide | AUCt | 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr |
| AUCinf of Leuprolide | AUCinf | 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr |
| Cmax of Leuprolide | Cmax | 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Leuprolide | Tmax | 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr |
| t1/2 of Leuprolide | t1/2 | 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |