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The purpose of this study is to evaluate the PK effects of SHR4640 tablets on repaglinide and midazolam, as well as the effects of SHR4640 tablets on the QT interval in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR4640 group A | Experimental |
| |
| SHR4640 group B | Experimental |
| |
| SHR4640 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repaglinide; midazolam; SHR4640 | Drug | repaglinide; midazolam; SHR4640 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: Cmax | Day 1 to Day 24 | |
| The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: AUC0-t | Day 1 to Day 24 | |
| The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: AUC0-inf | Day 1 to Day 24 | |
| QTcF corrected for baseline and placebo after oral administration of SHR4640 tablets( ΔΔ QTcF) | Day 1 to Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: Tmax | Day 1 to Day 24 | |
| The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: t1/2 | Day 1 to Day 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 300041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39530130 | Derived | Cheng Y, Hu X, Pei Z, Zhang Z, Lin H, Feng S, Gao Z, Ma Y, Cao Z, Zhang Q, Zheng L, Zhang W, Shen K, Hu W. Evaluating the drug-drug interactions of SHR4640 on repaglinide and midazolam in healthy subjects. Expert Opin Drug Metab Toxicol. 2025 Jan-Feb;21(2):217-224. doi: 10.1080/17425255.2024.2428367. Epub 2024 Nov 14. |
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This study is a single-center, randomized, double blind, three-period, and three-group parallel design trial, consisting of three groups (group A、 group B and placebo group).
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| repaglinide; midazolam; SHR4640; SHR4640 placebo |
| Drug |
repaglinide; midazolam; SHR4640; SHR4640 placebo |
|
| repaglinide; midazolam; SHR4640 placebo | Drug | repaglinide; midazolam; SHR4640 placebo |
|
| The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: CL/F | Day 1 to Day 24 |
| The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: Vz/F | Day 1 to Day 24 |
| PK parameters for oral SHR4640 tablets: Cmax | Day 1 to Day 24 |
| PK parameters for oral SHR4640 tablets: AUC0-t | Day 1 to Day 24 |
| PK parameters for oral SHR4640 tablets: Tmax | Day 1 to Day 24 |
| Safety indicators: adverse events | Screening period up to Day 28 |
| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C072379 | repaglinide |
| D008874 | Midazolam |
| C000720748 | ruzinurad |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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