A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects
Evaluation of the Relative Bioavailability of HRS-9813 Capsule and Tablet in Healthy Subjects and the Effect of Food on the Pharmacokinetics of HRS-9813 Capsule
1 other identifier
interventional
12
1 country
1
Brief Summary
This is a phase Ⅰ study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2025
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
May 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2025
CompletedJuly 8, 2025
July 1, 2025
1 month
April 15, 2025
July 4, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Maximum observed concentration of HRS-9813 capsule (Cmax)
Day 1-Day 23.
Maximum observed concentration of HRS-9813 tablet (Cmax)
Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)
Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)
Day 1-Day 23.
Secondary Outcomes (3)
Adverse events (AEs)
Day 1-Day 23.
Time to Cmax of HRS-9813 capsule (Tmax).
Day 1-Day 23.
Time to Cmax of HRS-9813 tablet (Tmax).
Day 1-Day 23.
Study Arms (2)
HRS-9813 Capsule Group
EXPERIMENTALHRS-9813 Tablet Group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Aged 18-45 years.
- Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2.
- Subjects not with clinically significant vital signs and laboratory tests.
- Take contraception measures.
You may not qualify if:
- Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug.
- Severe infection, severe trauma or major surgery.
- Any medications in the two weeks before screening or baseline period.
- History of blood donation or severe blood loss.
- Have been vaccinated within 2 weeks before the screening or baseline period.
- History of smoking or excessive alcohol or drug abuse.
- Other situations that the researcher judges to be unsuitable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2025
First Posted
April 22, 2025
Study Start
May 4, 2025
Primary Completion
June 3, 2025
Study Completion
June 23, 2025
Last Updated
July 8, 2025
Record last verified: 2025-07