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This study will have one stage consisting of multiple treatment visits. The study is designed to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy volunteers in various formulation. The study is also designed to assess the reproducibility of pharmacokinetic profiles with various formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator | Active Comparator | Subcutaneous injection of Teriparatide |
|
| Oral PTH (1-34) | Experimental | Oral administration of pill with API with different optimizations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | subcutaneous standard injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration | Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile | 60-522 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | throughout the study beginning from the time the subject signs the consent form until the end of study, subjects will complete the following evaluations: Vital signs (blood pressure, heart rate, oral temperature) Clinical laboratory evaluations, hematology, chemistry Physical Exam ECG | 60-522 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yosef Caraco, MD | Hadassah Ein Kerem Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D010281 | Parathyroid Hormone |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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| Oral PTH (1-34) |
| Drug |
Different optimization of API |
|
|
| D000602 | Amino Acids, Peptides, and Proteins |