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NOT YET RECRUITING
NCT07703904
PHASE1

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

Sponsor: Hemay Pharmaceutical PTY. LTD.

View on ClinicalTrials.gov

Summary

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

Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of Hemay5259 Extended-Release Tablet in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-07-01

Completion Date

2026-10-31

Last Updated

2026-07-15

Healthy Volunteers

Yes

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

Locations (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia