A Food Effect Study of SPH5030 Tablets.

April 15, 2024 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China
        • West China Second Hospital ,Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Drug: SPH5030
SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.
Drug: SPH5030
SPH5030 tablets：400mg, orally, Dosing in the fed state followed by fasted dosing.
Experimental: Group B
Drug: SPH5030
SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.
Drug: SPH5030
SPH5030 tablets：400mg, orally, Dosing in the fed state followed by fasted dosing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: Approximately 2 months
PK（Pharmacokinetics）
Approximately 2 months
Peak time（Tmax）
Time Frame: Approximately 2 months
PK（Pharmacokinetics）
Approximately 2 months
Area under the plasma concentration versus time curve (AUC)
Time Frame: Approximately 2 months
PK（Pharmacokinetics）
Approximately 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Approximately 2 months
Adverse event type, incidence, duration
Approximately 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Actual)

March 25, 2024

Study Completion (Actual)

March 25, 2024

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SPH5030-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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