A Food Effect Study of SPH5030 Tablets.

Phase 1CompletedNCT06372223

Shanghai Pharmaceuticals Holding Co., Ltd16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

SPH5030DRUG

SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.

SPH5030DRUG

SPH5030 tablets：400mg, orally, Dosing in the fed state followed by fasted dosing.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

West China Second Hospital ,Sichuan University

Chengdu, China

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

PK（Pharmacokinetics）

Time frame: Approximately 2 months

Peak time（Tmax）

PK（Pharmacokinetics）

Time frame: Approximately 2 months

Area under the plasma concentration versus time curve (AUC)

PK（Pharmacokinetics）

Time frame: Approximately 2 months

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events

Adverse event type, incidence, duration

Time frame: Approximately 2 months

Data from ClinicalTrials.gov

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