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drugset / Trial / NCT05316857

DDI Study of Orelabrutinib

NCT05316857 ↗

Phase 1 Completed 36 enrolled Beijing InnoCare Pharma Tech Co., Ltd.
RandomizedParallel-groupOpen-labelOther

Summary

This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects.

Timeline

Start
2021-12-16
Primary completion
2022-01-04
Completion
2022-06-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule — —
Subject Orelabrutinib Small molecule — —
Subject Rifampin Small molecule 600 mg —

Indications

No indication recorded.