A Food Effect Study of SPH5030 Tablets.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2024-03-25

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group Type EXPERIMENTAL

SPH5030

Intervention Type DRUG

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

Group B

Group Type EXPERIMENTAL

SPH5030

Intervention Type DRUG

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

Interventions

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SPH5030

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

Intervention Type DRUG

SPH5030

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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes