Healthy
Conditions
Keywords
XZP-3287, Food Effect, Pharmacokinetics
Brief summary
This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal.
Interventions
DRUGXZP-3287
Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast
Sponsors
Xuanzhu Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria 1. Healthy male or female subjects aged 18 to 65 years (including 18 and 65); 2. Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive). 3. No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system. 4. Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication. 5. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent
Exclusion criteria
1. Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients 2. Abnormal clinical tests and clinical significance judged by the investigator 3. Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment 4. History of drug use, or drug abuse screening positive 5. Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period 6. Heavy drinking or regular drinking in the six months preceding the screening period 7. Use of any prescription drug or Chinese herbal medicine within 4 weeks prior to enrollment, or use of any over-the-counter drug, any vitamin product, health care drug within 14 days prior to enrollment; 8. Treatment with an investigational drug within 3 months 9. Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening. 10. Had a severe infection, trauma or major surgery within 4 weeks of screening 11. Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes 12. Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required. 13. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive. 14. Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet 15. habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period 16. habitual consumption of grapefruit juice during the study period 17. have difficulty in blood collection or cannot tolerate vein puncture for blood collection 18. As determined by the investigator, the subject has other factors that are not suitable for the study -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary PK Endpoints | day 1~day 21 | Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary PK measures | day 1~day 21 | Tmax |
| Safety and tolerability | Up to 14 days after last dose | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 |
Countries
China
Contacts
Primary ContactCuilan Xiao
Outcome results
None listed