Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants
Summary
This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of vorolanib tablets in healthy trial participants. The study consists of two treatment groups. The rifampicin group is planned to enroll 18 healthy trial participants. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin. The itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of vorolanib tablets. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
Timeline
- Start
- 2026-09
- Primary completion
- 2027-01
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Rifampicin | Small molecule | — | Oral |
| Subject | Vorolanib | Small molecule | — | Oral |
Indications
No indication recorded.