Clinical trial
A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.
Name
SPH5030-102
Description
The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.
Trial arms
Trial start
2024-03-04
Estimated PCD
2024-03-25
Trial end
2024-03-25
Status
Completed
Phase
Early phase I
Treatment
SPH5030
SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.
Arms:
Group A
SPH5030
SPH5030 tablets：400mg, orally, Dosing in the fed state followed by fasted dosing.
Arms:
Group B
Size
16
Primary endpoint
Peak Plasma Concentration (Cmax)
Approximately 2 months
Peak time（Tmax）
Approximately 2 months
Area under the plasma concentration versus time curve (AUC)
Approximately 2 months
Eligibility criteria
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 exclusion criteria.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}
Updated at
2024-04-17
1 organization
1 product
1 indication
Organization
Shanghai Pharmaceuticals HoldingProduct
SPH5030Indication
Advanced Solid Tumor