A Food Effect Study of SPH5030 Tablets.
- Registration Number
- NCT06372223
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Fully informed subjects who voluntarily sign the ICF；
- Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.
Exclusion Criteria
- Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;
- Subjects with abnormal test results during the screening period；
- Subjects who have difficulty in venous blood collection;
- Subjects who cannot accept uniform diet or have difficulty swallowing;
- Other situations that meet the exclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group B SPH5030 - Group A SPH5030 -
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) Approximately 2 months PK（Pharmacokinetics）
Peak time（Tmax） Approximately 2 months PK（Pharmacokinetics）
Area under the plasma concentration versus time curve (AUC) Approximately 2 months PK（Pharmacokinetics）
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events Approximately 2 months Adverse event type, incidence, duration
Trial Locations
- Locations (1)
West China Second Hospital ,Sichuan University
🇨🇳Chengdu, China