None listed
Conditions
Interventions
(Fasting) R-T group:In the fasting state, the subjects took rabeprazole sodium enteric-coated tablets for 7 consecutive days, and then took the palbociclib reference preparation in the first cycle, an
(Fasting) T-R group:In the fasting state, the subjects took rabeprazole sodium enteric-coated tablets for 7 consecutive days, and took the palbociclib test preparation in the first cycle, and the refe
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 51 Years
Inclusion criteria
Inclusion criteria: All the entry criteria must be met: 1) The subject fully understands the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form before the start of any study procedures; 2) Male and female subjects aged = 18 years old, with an appropriate proportion of single-sex subjects; 3) Male weight = 50.0 kg, female weight = 45.0 kg; Body mass index (BMI) in the range of 19.0~26.0 kg/m2 (BMI = weight (kg)/height 2 (m2), including the cut-off value); 4) The subject has no history of chronic or serious diseases of cardiovascular, digestive, urinary, respiratory, blood and lymphatic, endocrine, immunologic, psychiatric, neurological, skin, eye, and skeletal systems (inquiry); 5) Subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures and no sperm and egg donation plans from 1 month before screening to 6 months after the last dose of study drug; 6) Subjects voluntarily signed the informed consent form, can communicate well with the investigator, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Exclusion is defined if one of the following exclusion criteria is met: 1) Dysphagia; 2) Those who have any history of surgery, trauma that may affect the safety of the trial or the metabolism process of the drug in vivo, or who have undergone surgery that will affect the absorption, distribution, metabolism, and excretion of the drug within 3 months before screening, or who plan to undergo surgery during the study; 3) Those who have irregular bowel movements, nausea and vomiting 7 days before screening, and the investigator thinks that it is not suitable to participate in the experiment; 4) Those who cannot tolerate venipuncture or have a history of fainting and blood sickness or difficulty in blood collection; 5) Those who have used drugs within 3 months before screening or have a history of drug abuse in the past 3 years or a positive urine drug screen; 6) Those who have taken clinical research drugs within 3 months before screening or who do not come to participate in clinical trials; 7) Those who donated or lost =400 mL of blood within 3 months before screening, and those who received blood transfusion or used blood products; 8) Female subjects who are lactating during the screening period or during the test or have positive pregnancy test results; 9) Those who have taken any drugs that change the activity of liver enzymes or drugs that interact with palbociclib within 28 days before screening (CYP3A inhibitors and inducers (such as: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole; carbamazepine, enzalutamide, phenytoin, rifampicin, and St. John's wort)) and drugs that interact with rabeprazole sodium enteric-coated tablets (such as atazanavir sulfate, digoxin, methylgoxin, itraconazole, gefitinib, antacids containing aluminum hydroxide gel/magnesium hydroxide); 10) Those who have taken any drugs or health products within 2 weeks before screening; 11) Those with a history of drug or food allergies or allergies; 12) Those who smoke more than 5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the trial; 13) Those who have consumed more than 14 units of alcohol per week (1 unit ˜ 357 mL of beer or 43 mL of liquor with 40% alcohol or 147 mL of wine with 12% alcohol) per week within 3 months before screening, or those who cannot abstain from alcohol during the test; 14) Those who drank excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) every day within 3 months before screening; 15) Those who have received any vaccine within half a month before screening; 16) Those who have special requirements for diet and cannot accept a unified diet; 17) Patients with abnormal laboratory tests (blood analysis, urinalysis + urine sediment quantification, blood biochemistry, coagulation, hepatitis B, hepatitis C, HIV, syphilis test, thyroid function test, blood pregnancy test (female)), vital signs examination, physical examination, 12-lead electrocardiogram, chest X-ray examination with abnormal clinical significance; 18) Those who have consumed fruits or related products (such as grapefruit, grapefruit, dragon fruit, mango) that affect drug metabolism within 7 days before taking antacids, or cannot stop eating the above special diet during the test; 19) Within 48 hours before taking antacids: those who suffer from diseases or have taken d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2;Tmax; | — |
Countries
China
Contacts
Public ContactBai Wanjun
Hebei General Hospital
Outcome results
None listed