A Food Effect Study of SPH5030 Tablets.

Shanghai Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SPH5030

Study type: Interventional

Funder types: Industry

Identifiers

NCT06372223

SPH5030-102

Details and patient eligibility

About

The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group A

Experimental group

Treatment:

Drug: SPH5030

Drug: SPH5030

Group B

Experimental group

Treatment:

Drug: SPH5030

Drug: SPH5030