Advanced Solid Tumor
Conditions
Brief summary
The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.
Interventions
DRUGSPH5030
SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Fully informed subjects who voluntarily sign the ICF； 2. Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.
Exclusion criteria
1. Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study; 2. Subjects with abnormal test results during the screening period； 3. Subjects who have difficulty in venous blood collection; 4. Subjects who cannot accept uniform diet or have difficulty swallowing; 5. Other situations that meet the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Approximately 2 months | Adverse event type, incidence, duration |
Countries
China
Outcome results
None listed