Status:
COMPLETED
Food Effect Study of HSK47388 in Healthy Subjects
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Pharmaceutical Preparations
Health Adult Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ad...
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: Partic...
Eligibility Criteria
Inclusion
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
- Able and willing to attend the necessary visits to the study site
Exclusion
- Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
- Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
- Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.
Key Trial Info
Start Date :
August 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07192692
Start Date
August 8 2025
End Date
August 28 2025
Last Update
September 25 2025
Active Locations (1)
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1
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China