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SPH3348 Tablets in a Single-center, Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design Food Effect Study in Healthy Chinese Subjects

NCT06652997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-10-22

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK.

Conditions

  • Antitumor Drug
  • Pharmacokinetics

Interventions

DRUG

SPH3348

Single oral administration of SPH3348 tablets（480mg） under fasting and fed conditions

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    collaborator INDUSTRY

  • West China Second University Hospital

    lead OTHER

Principal Investigators

  • yu · National Drug Clinical Trial Institution of West China Second Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2022-08-14
Completion
2022-11-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652997 on ClinicalTrials.gov