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The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
Participants will receive single-dose of either test or reference octreotide microsphere formulations.
Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental |
| |
| Reference | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The test octreotide microsphere | Drug | A single intramuscular dose of the test octreotide microsphere 30mg, |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-28d | The area under the concentration-time curve from dosing to Day 28 | Day 0-28 |
| AUC28-56d | The area under the concentration-time curve from Day 28 to Day 56 | Day 28-56 |
| AUC0-t | The area under the concentration-time curve from dosing to the last quantifiable time-point | Day 0-82 |
| AUC0-∞ | The area under the concentration-time curve extrapolated to infinity | Day 0-82 |
| Cmax | The maximum drug concentration | Day 0-82 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40353390 | Derived | Wang C, Li X, Gu X, Hu H, Lv Z, Sun Y, Li Y, Hao C, Liu Y, Fu Y, Yang Q, Cao Y. Pharmacokinetic and Bioequivalence Evaluation of Prolonged-Release Octreotide Acetate Microspheres in Healthy Human Subjects. Clin Pharmacol Drug Dev. 2025 Jul;14(7):505-510. doi: 10.1002/cpdd.1521. Epub 2025 May 12. |
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| The reference octreotide microsphere | Drug | A single intramuscular dose of the reference octreotide microsphere 30mg |
|