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To Evaluate the Safety, Tolerability, Pharmacokinetics and the Effect of Food on the Hemay5259 Sustained-release Tablets in Healthy Subjects.

NCT07703904 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-15

No results posted yet for this study

Summary

Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects

Conditions

  • Pharmacokinetics

Interventions

DRUG

Hemay5259 group 1

Food influence test: single administration of the drug, multiple dosing trial: administration once daily

DRUG

placebo group 1

Food effect trial: single administration of the drug, multiple dosing trial: administration once daily

DRUG

Hemay5259 group 2

Food influence test: single administration of the drug, multiple dosing test: administration once daily

DRUG

Placebo group 2

Food influence test: single administration of the drug, multiple dosing test: administration once daily

Sponsors & Collaborators

  • Hemay Pharmaceutical PTY. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-08-31
Completion
2026-10-31

Countries

  • Australia

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 NCT07703904 on ClinicalTrials.gov