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The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotilavir sodium tablet | Experimental |
| |
| Dotilavir sodium tablet(Tivicay@) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotilavir sodium tablet | Drug | The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 31 days |
| Area under the plasma concentration versus time curve (AUC0-t) | Evaluation of Area under the plasma concentration versus time curve (AUC0-t) | 31days |
| Area under the plasma concentration versus time curve (AUC0-∞) | Evaluation of Area under the plasma concentration versus time curve (AUC0-∞) | 31days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 31days |
| Incidence of abnormal blood pressure | Monitor both systolic and diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yu Cao, doctor | Contact | 86 18661809090 | caoyu1767@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266003 | China |
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| Dotilavir sodium tablet(Tivicay@) | Drug | The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg. |
|
| 31 days |