Bioequivalence Study of capecitabine tablet
- Conditions
- Neoplasms
- Registration Number
- KCT0006278
- Lead Sponsor
- Boryung Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
1) Those aged 19 to 70 years old at the time of the screening test
2) Patients recognized as colorectal cancer, breast cancer, and gastric cancer, who are undergoing follow-up after curative treatment† and whose follow-up period is within 5 years from the date of first administration of the investigational product
† Curative treatment: It is defined as chemotherapy after surgery or after surgery and radiation therapy
3) Those who judged by investigator to be suitable for clinical laboratory tests such as serum tests, hematology tests, blood chemistry tests, urinalysis, blood coagulation tests, etc., and 12-lead electrocardiogram tests within 3 weeks before administration of the IP
4) Those who can take BR9009 and BR9009A orally
5) Patients with a body mass index (BMI) of 19.0kg/m2 or more and 30.0kg/m2 or less
6) ECOG Performance Status (PS)§ 0~2 patients
7) Those who voluntarily signed the informed consent to participate in this study after being given sufficient detailed explanation about the study and fully understanding
1) Those who has current disease or medical history in clinically significant cardiovascular system (myocardial infarction/ischemia, angina, arrhythmia, heart failure, cardiomyopathy, etc.), respiratory system, liver, kidney, nervous system, endocrine system, blood and tumors (excluding colorectal cancer, breast cancer, and stomach cancer), mental or urinary system
However, if there is a history of hypertension, there is no change in the amount of drugs to be taken for 3 months, and the range of drugs to be taken is within the range of drugs described below, and those who have no signs of complications related to the disease may participate.
? Amlodipine, nifedipine, lercanidipine, lacidipine, felodipine, cilnidipine (CCB) / Losartan, valsartan, candesartan, olmesartan, irbesartan, telmisartan, eprosartan (ARB) /Ramipril, enalapril, cilazpril, fosinopril, cilazpril, lisinop, imapril inhibitor)
? Aspirin 100 mg
? One of Lovastatin, simvastatin, atorvastatin, rosuvastatin, pitavastatin, pravastatin
2) Persons with clinically significant hypersensitivity reactions or a history of clinically significant hypersensitivity reactions to the active ingredients or components of clinical investigational product or other drugs or additives
3) Patients who have had severe unexpected reactions to fluoropyrimidine-based drugs or who have confirmed hypersensitivity to fluorouracil
4) Patients known for dihydro-pyridine dehydrogenase (DPD) deficiency
5) Patients who are taking capecitabine and drugs that have drug interactions (allopurinol, soribudin and brivudine, warfarin, phenytoin, etc.) or who must be administered during the study period
6) Patients who Tegapur/Gimeracil/Oteracyl Potassium combination drug should be administered or should be administered from 7 days prior to the first administration of the clinical investigational product until the test is completed.
7) Persons who showed a value that is included in any one of systolic blood pressure = 140mmHg or <90mmHg, diastolic blood pressure = 95mmHg or <60mmHg, pulse rate> 100 times/min in the vital signs measured in the sitting position during the screening test
8) Patients with severe renal failure (creatinine clearance less than 30mL/min)
9) Patients with severe leukopenia, neutropenia, or thrombocytopenia or patients with myelosuppression
10) Patients with severe liver damage
11) If there is a grade 2 or higher limb syndrome at the time of the screening test, or if the grade is not expected to decrease to less than grade 2 until the first administration of the investigational product
12) Patients who have already taken this formulation within 4 weeks prior to the first administration of the investigational product, or who have received other chemotherapy and radiation therapy, or who must receive it during the study period.
13) Those who participated in other clinical trials or bioequivalence studies within 6 months prior to the first administration of the investigational product (however, the end of the previous clinical trial is determined as the last administration date).
14) Those who donated whole blood within 2 months before the first administration of the investigational product, or those who donated or received a blood transfusion within 1 month
15) Those who have been on an abnormal diet that may affect the absorption, distribution, metabolism and excretion of drugs (e.g. grapefruit juice (more than 1L per day) within 7 days prior to administration of investigat
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax of Capecitabine
- Secondary Outcome Measures
Name Time Method AUCinf of Capecitabine;Tmax of Capecitabine;t1/2 of Capecitabine;CL/F of Capecitabine;Vd/F of Capecitabine;AUCt/AUCinf(%) of Capecitabine