Pulmonary Fibrosis
Conditions
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.
Interventions
DRUGHRS-9813 Capsule
HRS-9813 capsule.
DRUGHRS-9813 Tablet
HRS-9813 tablet.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18-45 years. 2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2. 3. Subjects not with clinically significant vital signs and laboratory tests. 4. Take contraception measures.
Exclusion criteria
1. Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug. 2. Severe infection, severe trauma or major surgery. 3. Any medications in the two weeks before screening or baseline period. 4. History of blood donation or severe blood loss. 5. Have been vaccinated within 2 weeks before the screening or baseline period. 6. History of smoking or excessive alcohol or drug abuse. 7. Other situations that the researcher judges to be unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Outcome results
None listed