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A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
Sponsor: Betta Pharmaceuticals Co., Ltd.
Summary
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
Official title: A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2024-07
Completion Date
2024-12
Last Updated
2024-07-09
Healthy Volunteers
Yes
Conditions
Interventions
Ensartinib
225 mg oral dose on day 1 in period 1 and on day 18 in period 2
Rifampicin
600 mg QD from day 9 to day 22 in period 2
Itraconazole
200 mg QD from day 9 to day 19 in period 2
Ensartinib
100 mg oral dose on day 1 in period 1 and on day 12 in period 2
Locations (1)
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China