Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008, China
NCT Number: NCT05928988
This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Nanjing, Jiangsu, 210008, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Time frame: Baseline up to Day 18
Time frame: Baseline up to Day 18
Time frame: Baseline up to Day 18
Time frame: Baseline up to Day 18
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects
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