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The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.
This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Single subcutaneous injection of two teriparatide products (PF708 and Forteo) |
|
| Sequence B | Experimental | Single subcutaneous injection of two teriparatide products (Forteo and PF708) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Single subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum area-under-the-curve (AUC) of PF708 and Forteo | 24 hours | |
| Serum maximum concentration (Cmax) of PF708 and Forteo | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo | 0-24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert C Chen, M.D. | Pfenex, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Evansville | Indiana | 47710 | United States |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |