NCT07192692

Food Effect Study of HSK47388 in Healthy Subjects

A Phase I Clinical Study to Evaluate the Effect of Food on the Pharmacokinetics of HSK47388 Tablets in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study consists of 3 treatment sequences in a 3-period, crossover design. Approximately 15 healthy adult participants will be randomized 1:1:1 to one of the following sequences: Sequence A: Participants will receive HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3）. Sequence B: Participants will receive administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3），HSK47388 orally in the fasted state (condition 1). Sequence C: Participants will receive HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3),HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2) . All participants will remain under clinical observation for safety monitoring and pharmacokinetic sampling throughout each period. Blood, urine and fecal samples will be collected at defined intervals for the analysis of HSK47388 and its metabolites. Each participant's total study duration will be approximately 37 days, including screening, treatment, and follow-up.

Conditions

• Pharmaceutical Preparations
• Health Adult Subjects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-08
• Primary completion: 2025-08-26
• Completion: 2025-08-28
• First posted: 2025-09-25
• Last updated: 2025-09-25

Locations

1 site across 1 country: China