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Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects
Sponsor: Jemincare
Summary
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.
Official title: A Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX003142 Tablets in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-11-05
Completion Date
2025-03-21
Last Updated
2024-10-26
Healthy Volunteers
Yes
Interventions
Cohort 1: JMKX003142 and itraconazole
JMKX003142: Dose: 3 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg itraconazole once: Day8, once only in the morning. Itraconazole:Dose: 200mg once;Day5-Day7 and Day9-Day11, QD
Cohort 2: JMKX003142 and rifampicin
JMKX003142: Dose: 6 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg rifampicin once: Day14, once only in the morning. Rifampicin:Dose: 600mg once;Day5-Day13 and Day15-Day17, QD