Status:
COMPLETED
Drug-drug Interaction Study of SPH3127
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Drug Drug Interaction
Eligibility:
MALE
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent;
- Chinese Male ≥18 and ≤45 years；
- BMI≥18.5 and ≤26.0 kg/m2 and a weight ≥50.0 kg;
- Normal or no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the vital signs, physical examination, clinical laboratory tests, and 12-lead ECG.
- Subjects agreed to have no family planning during the study period and within 6 months after the last study drug administration, voluntarily take effective contraceptive measures and have no sperm donation plan. Non-drug contraceptive measures will be used voluntarily during the trial.
- Subjects can communicate well with investigators, understand and comply with the requirements of this trial.
Exclusion
- Patients with diseases that need to be excluded, not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone, and other systems;
- History of allergic diseases;
- History of dysphagia or any gastrointestinal illness that affects drug absorption;
- Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug;
- People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before screening;
- Prescribed medications, over-the-counter medications, dietary supplements, or Chinese herbal medicines were taken within 14 days prior to initial administration of the study drug;
- Unwilling to avoid vigorous exercise from 48 hours before the first administration of the study drug to the end of the study;
- Used of any drug that inhibits or induces hepatic metabolism of the drug in the 28 days prior to taking the study drug.
- Those who have special dietary requirements and cannot follow a uniform diet;
- Assessed by the investigators as unsuitable for participating in the study.
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05359055
Start Date
December 13 2021
End Date
January 21 2022
Last Update
July 29 2022
Active Locations (1)
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1
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China, 610044