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The study is being conducted to evaluate drug interaction between HS-10234 and Emtricitabine after multiple dose in healthy subjects.
The study includes two parts. Part 1 is to evaluate the impact of Emtricitabine on HS-10234. Part 2 is to evaluate the impact of HS-10234 on Emtricitabine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm for each part: two arms | Other | PART1:In the first period, HS-10234 will be administered at 25 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days. PART2:In the first period, Emtricitabine will be administered at 200 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10234 | Drug | HS-10234 |
| |
| Emtricitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine | Cmax | 0 - 24 hour on 7th day |
| Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine | AUC0-tau | 0 - 24 hour on 7th day |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of HS-10234's metabolite tenofovir-diphosphate in peripheral blood mononuclear cells. | Concentration | 0 - 24 hour on 7th day |
| Incidence of AEs, | laboratory abnormalities (based on hematology, biochemistry, and urinalysis tests) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoping Yang | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34727366 | Derived | Luo Y, Chen W, Yang G, Zou C, Huang J, Kuang Y, Shen K, Zhang B, Yang S, Xiang H, Li Z, Pei Q. Study on Pharmacokinetic Interactions Between HS-10234 and Emtricitabine in Healthy Subjects: An Open-Label, Two-Sequence, Self-Controlled Phase I Trial. Infect Dis Ther. 2022 Feb;11(1):175-186. doi: 10.1007/s40121-021-00555-y. Epub 2021 Oct 30. |
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| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Drug |
Emtricitabine |
|
| 0 - 23 day |
| Incidence of AEs, | body temperature | 0 - 23 day |
| Incidence of AEs, | respiratory rate | 0 - 23 day |
| Incidence of AEs, | blood pressure | 0 - 23 day |
| Incidence of AEs, | pulse rate | 0 - 23 day |
| Incidence of AEs, | Resting 12-lead ECG parameters(ECG QT Interval) | 0 - 23 day |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |