West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610044, China
NCT Number: NCT05359055
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
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Notify Me18 year–45 year
Male
Interventional
Phase 1 / Phase 2
Chengdu, Sichuan, 610044, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100mg once daily on Day 1 and Day 8
200mg once daily from Day 3 to Day10.
600mg once daily from Day 3 to Day13.
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 42 days
Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs.
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Shanghai Pharmaceuticals Holding Co., Ltd
Industry
An Open-label, Fixed Sequence Study to Evaluate the Effects of Multi-dose of Itraconazole or Rifampin on the Pharmacokinetic Profiles of Single Dose of SPH3127 in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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