MedTrace Logo

Food Effect Study of HSK47388 in Healthy Subjects

NCT07192692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-25

No results posted yet for this study

Summary

This is a Phase 1, open-label, randomized, three-period crossover trial study to evaluate the effect of food and dosing and meal timing intervals on the pharmacokinetics (PK) of HSK46575 in healthy adult participants ,with an exploratory assessment of excretion pathways and excretion rates. Safety and tolerability will also be evaluated.

Conditions

  • Pharmaceutical Preparations
  • Health Adult Subjects

Interventions

DIETARY_SUPPLEMENT

fast

fast state

DIETARY_SUPPLEMENT

low fat meal

take HSK47388 with low fat meal

DIETARY_SUPPLEMENT

take meal after HSK47388 administration

take meal after HSK47388 administration at specific time

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2025-08-26
Completion
2025-08-28

Countries

  • China

Study Locations

More Related Trials

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 NCT07192692 on ClinicalTrials.gov