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This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study.
64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be given subcutaneous injection once, and the washout period will be 72 hours, and each subject will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001) is injected in the second period.
If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs are considered to be bioequivalent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Other | The test drug (SAL001) is administrated once by subcutaneous injection in the first period, and the reference drug (FORSTEO) is administrated once by subcutaneous injection in the second period. |
|
| Sequence B | Other | The reference drug (FORSTEO) is administrated once by subcutaneous injection in the first period, and the test drug (SAL001) is administrated once by subcutaneous injection in the second period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL001 | Biological | administrated once by subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: area under the plasma concentration time curve from-time zero to time t (AUC0-t) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: peak plasma concentration (Cmax) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: area under the plasma concentration time curve from time zero to time infinity (AUC0-∞) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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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| FORSTEO |
| Biological |
administrated once by subcutaneous injection |
|
| PK parameters: time to reach peak drug concentration (Tmax) |
Central lab will be used to detect the plasma concentration of drugs. |
| Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: half-life (t1/2) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: AUC extrapolated from Tmax to infinity in percentage of the total AUC (AUC%extrap) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: time to last measurable concentration (Tlast) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: terminal elimination rate constant (λz) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: apparent total clearance (CL/F) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: apparent distribution volume (Vz/F) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: mean residence time from time zero to t (MRT0-t) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PK parameters: mean residence time from time zero to infinity (MRT0-∞) | Central lab will be used to detect the plasma concentration of drugs. | Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4 |
| PD parameters: area under the serum concentration time curve from-time zero to time t (AUC0-t) | Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters. | Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4 |
| PD parameters: area under the serum concentration time curve from time zero to time infinity (AUC0-∞) | Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters. | Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4 |
| PD parameters: peak serum concentration (Cmax) | Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters. | Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4 |
| PD parameters: time to reach peak serum concentration (Tmax) | Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters. | Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |