Pharmacokinetics of CMS-D001 tablets
Conditions
Interventions
A Group (Fasting - Postprandial):CMS-D001 tablet 100 mg, single oral administration. Fasting administration in the first cycle, postprandial (high-fat meal) administration in the second cycle.
B Group (Postprandial - Fasting):CMS-D001 tablet 100 mg, single oral administration. Postprandial (high-fat meal) administration in the first cycle, fasting administration in the second cycle.
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and provide written informed consent. 2. Able to communicate well with the investigator, understand and comply with all requirements and restrictions of the study, and complete the study in accordance with the protocol. 3. Male or female participants aged 18 to 45 years (inclusive), with age determined on the day of signing the informed consent form. 4. Body mass index (BMI) at screening of 19.0 to 26.0 kg/m^2 (inclusive); female participants with body weight = 45.0 kg, and male participants with body weight = 50.0 kg. 5. Fertile participants (including their partners) have no plans to conceive, donate oocytes or sperm from the date of signing the informed consent form until 3 months after the last study drug administration, and must comply with relevant contraceptive requirements during this period.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of severe allergies, including allergies to food or drugs, or who are allergic to the investigational product or its components. 2. Subjects with a significant medical history or clinical manifestations of any cardiovascular, respiratory, digestive, genitourinary, hematological, endocrine and metabolic, rheumatic immune, neuropsychiatric, or musculoskeletal disorders requiring medication and/or other therapy (including dietary restrictions and physical therapy), whom the investigator deems ineligible for participation in this study. 3. subjects who had a severe infectious disease (e.g., requiring hospitalization or parenteral antibiotic therapy or opportunistic infection) within 6 months prior to screening, or a history of chronic or recurrent infectious diseases. 4. Subjects with a history of dysphagia or any gastrointestinal disease that may affect drug absorption, including but not limited to malabsorption syndrome, inflammatory bowel disease, celiac disease, gastrectomy, cholecystectomy, or intestinal resection (excluding appendectomy). 5. Subjects with lactose intolerance (those who have experienced diarrhea after milk consumption). 6. Subjects with a history of major trauma or who underwent major surgery (e.g., gastrointestinal surgery, oncological surgery, etc.) within 8 weeks prior to screening, or subjects planning to undergo surgery during the study period. 7. Use of any prescription or non-prescription drugs (including Chinese herbal medicines, vitamins, minerals, and dietary supplements, etc.) within 2 weeks before dosing or at least 5 elimination half-lives, whichever is longer. 8. Use of any drugs or substances known to be CYP3A inducers or inhibitors, or P-gp inhibitors, within 2 weeks prior to dosing, or within 5 elimination half-lives of such drugs, whichever is longer. 9. Subjects who received a vaccination within 4 weeks prior to screening, or who plan to receive a vaccination during the study period. 10. Subjects who participated in any other clinical study involving investigational drugs or medical devices within 3 months prior to screening, or who plan to participate in such clinical studies during the present study, or who are within 5 elimination half-lives of the prior study drug, whichever is longer. 11. Subjects with a history of drug abuse within 6 months prior to screening, or with a positive result on any item of the drug abuse test. 12. Subjects who consumed more than 14 units of alcohol per week within 3 months prior to screening (1 unit of alcohol = 360 mL beer, 150 mL wine, or 45 mL distilled spirits), or with a positive breath alcohol test, or who are unable to abstain from alcohol during the study period. 13. Subjects who smoked more than 5 cigarettes per day on average within 3 months prior to screening, or who are unable to refrain from using any tobacco products during the study period. 14. Subjects who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months prior to screening. 15. Subjects who consumed special foods within 7 days prior to dosing, including grapefruit or grapefruit-related citrus fruits (e.g., limes, pomelos), pitaya, mango, carambola, papaya, pomegranate and/or xanthine-containing foods, caffeinated foods or beverages, etc.; or subjects who are unable to adhere to dietary restrictions during the study period. 16. Subjects who performed strenuous exercise or physical activity within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration (Cmax), area under the drug-time curve from 0 to the last quantifiable time point (AUC0-last), area under the drug-time curve from 0 to infinity time point (AUC0-inf); | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time (Tmax), lag time (t lag), terminal phase elimination half-life (t 1/2), apparent clearance rate (CL/F), and apparent distribution volume (Vz /F); | — |
Countries
China
Contacts
Public ContactDong Ruihua
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed