NCT06939504CompletedPhase 1
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
Guangdong Hengrui Pharmaceutical Co., Ltd1 site in 1 country12 target enrollmentStarted: May 4, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Maximum observed concentration of HRS-9813 capsule (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18-45 years.
- •Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m
- •Subjects not with clinically significant vital signs and laboratory tests.
- •Take contraception measures.
Exclusion Criteria
- •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.
Arms & Interventions
HRS-9813 Capsule Group
Experimental
Intervention: HRS-9813 Capsule (Drug)
HRS-9813 Tablet Group
Experimental
Intervention: HRS-9813 Tablet (Drug)
Outcomes
Primary Outcomes
Maximum observed concentration of HRS-9813 capsule (Cmax)
Time Frame: Day 1-Day 23.
Maximum observed concentration of HRS-9813 tablet (Cmax)
Time Frame: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)
Time Frame: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)
Time Frame: Day 1-Day 23.
Secondary Outcomes
- 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.)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Relative Bioavailability Study of HRS9531 in Healthy SubjectsType 2 DiabetesNCT05893576Fujian Shengdi Pharmaceutical Co., Ltd.50
Completed
Phase 1
A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and TabletsEndometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted ReproductionNCT05868057Jiangsu HengRui Medicine Co., Ltd.16
Completed
Phase 1
Study on the Bioavailability of SHR0302 in Healthy SubjectsHealthy SubjectsNCT04712838Jiangsu HengRui Medicine Co., Ltd.24
Completed
Phase 1
A Clinical Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy SubjectsBreast CancerNCT06619873Shandong Suncadia Medicine Co., Ltd.24
Completed
Phase 1
A SHR0302 BA Study on Healthy SubjectsAutoimmune DiseasesNCT06202612Jiangsu HengRui Medicine Co., Ltd.16