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The drug-drug interaction study had been designed to investigate the effect of Leritrelvir on the pharmacokinetics of Midazolam, Omeprazole, Rosuvastatin and the effect of Verapamil and Rifampin on the pharmacokinetics of Leritrelvir
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below: Period 1: 1 × 15-mg Midazolam tablet ,1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet Period 2: 6 × 400-mg Leritrelvir tablet+1 × 15-mg Midazolam tablet, 1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet |
|
| Experimental 2 | Experimental | All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below: Period 1: 1 × 400-mg Leritrelvir tablet Period 2: 5 × 240-mg verapamil tablet+1 × 400-mg Leritrelvir tablet Period 3: 8 × 600-mg rifampin capsule +1 × 400-mg Leritrelvir tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | oral |
| |
| Omeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic - Cmax | Maximum observed plasma concentration | 0-72 hours |
| Pharmacokinetic -Area under the curve(AUC) | Area under the curve | 0-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | The safety and tolerability of Leritrelvir alone and in combination with Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin will be examined. | Day1-Day31 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42062754 | Derived | Peng J, Chen J, Du XX, Li HJ, Qin RZ, Chen SH, Liu X, Cheng Q, Li XM, Huang DX, Duan L, Li MY, Wu WZ, Ye LK, Li YY, Xie ZH, Han K. Pharmacokinetic Drug-Drug Interaction of Leritrelvir in Healthy Chinese Volunteers: A Single-Arm, Open-Label, Dual-Cohort Study. Clin Drug Investig. 2026 Jun;46(6):609-618. doi: 10.1007/s40261-026-01556-w. Epub 2026 May 1. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D009853 | Omeprazole |
| D000068718 | Rosuvastatin Calcium |
| D014700 | Verapamil |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
oral |
|
| Rosuvastatin | Drug | oral |
|
| Verapamil | Drug | oral |
|
| Rifampin | Drug | oral |
|
| Leritrelvir | Drug | oral |
|
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D011743 | Pyrimidines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |