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To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence of the two formulations under fasting state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (T)-Reference (R) | Experimental | In this trial, 16 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
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| Reference (R)-Test (T) | Experimental | In this trial, 16 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test (T) | Drug | Abaloparatide injection, specification :3120 μg/1.56 ml(2000 μg/ml), drug information subject to actual supply, Qilu Pharmaceutical Co., LTD. The test preparations for the subjects are all from the same batch number. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 4 hours |
| Area under the plasma concentration versus time curve (AUC0-t) | Area under the drug concentration-time curve from time 0 to the 4h accurately measurable concentration at sample collection time | 4 hours |
| Area under the plasma concentration versus time curve (AUC0-∞) | Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao | Contact | 86-18661809090 | caoyu1767@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
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| Reference (R) | Drug | Abaloparatide injection (Tymlos®), specification :3120 μg/1.56 ml(2000 μg/ml), drug information is subject to actual supply, provided by Qilu Pharmaceutical Co., LTD. The reference preparations for the subjects were all from the same batch number. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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