None listed
Conditions
Interventions
Drug : Tegafur/Gimeracil/Oteracil potassium (25/7.25/24.5 mg), single oral dose
Sponsors
Myungmoon Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. between 20 and 70 years of age 2. gastric cancer or head and neck cancer patients who had been followed up after curative surgery (follow-up period = 5 years), with no tegafur/gimeracil/oteracil potassium administration required 3. subjects that are considered eligible for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis, etc.) - hemoglobin = 9.0 g/dL - neutrophil count = 1,500 mm3 - platelets = 100,000/ mm3 - total bilirubin = 3 times the upper limit of the normal range (ULN) - aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) = 2.5 times the ULN - serum creatinine = the ULN - creatinine clearance (estimated using the Cockcroft-Gault equation using serum creatinine concentrations) = 60 mL/min)) 4. patients being possible per-oral administration of TeGO 25 or TS-1® 25 capsules 5. body mass index (BMI) between 17.6 kg/m2 and 26.4 kg/m2 (BMI = body weight (kg)/{height (m)}2) 6. body surface area (BSA) = 1.25 m2 (BSA (m2) = height (cm)0.663 X body weight (kg)0.444 X 0.008883) 7. histologically or cytologically proved cancer patients 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 9. negative pregnancy test at screening, in case of female patients 10. patients who voluntarily signed a written informed consent and consent on private information utilization, approved by the Institutional Review Board of Kyungpook National University Hospital (KNUH, Daegu, Republic of Korea).
Exclusion criteria
Exclusion criteria: 1. use of any drug that could induce or inhibit drug metabolizing enzymes such as barbiturates, or history of alcohol abuse within 1 month before the start of the trial 2. patients who could not take S-1 3. use of S-1 within 4 weeks prior to the first administration of the study drug 4. patients within 6 months after subtotal gastrectomy, or patients with total gastrectomy, or patients with frequent relapse of peptic ulcer 5. participation in any other clinical trial within 12 weeks prior to the first administration of study drug, or patients on concomitant medications taken within 10 days before the start of the trial, that could affect the trial (excluding amlodipine, lecanidipine, losartan, valsartan, olmesartan, irbesartan, atenolol, or ramipril) 6. history of other surgery within 4 weeks prior to the first administration of the study drug 7. history of any other chemotherapy within 5 weeks prior to the first administration of the study drug 8. history of radiotherapy within 6 weeks prior to the first administration of the study drug 9. evidence of metastases to other organs (brain or bone etc.) other than gastric cancer 10. active infectious disease (any febrile disease with fever > 38°C ) 11. serious concurrent disease such as intestinal palsy, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, gastrointestinal bleeding, uncontrollable diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, hepatic failure, psychiatric disorder, cerebrovascular disease, or peptic ulcer in need of transfusion, or patients judged inappropriate for bioequivalence study by their physicians 12. patients with diarrhea in need of treatment (watery diarrhea) 13. women who are pregnant or breast-feeding women, or patients with reproductive potential who were unwilling to use an effective method of contraception, or patients with reproductive potential 14. patients who are taking phenytoin, warfarin, flucytosine, allopurinol, idoxuridine, leucovorin, dipyridamole, cimetidine, methoxsalen, leflunomide, letrozole, fluoropyrimidine, anti-cancer agent(fluroruracil, tegafur-uracil combination drug, tegafur doxifluridine, capecitabine, carmofur, Horinato-tegafur-uracil therapy, Rebohorinato-fluorouracil therapy), pilocarpine, or proton pump inhibitor 15. patients judged inappropriate for the study by their investigators 16. a medical history of serious hypersensitivity to the study drug 17. patients with serious myelosuppression 18. patients with serious renal disease 19. patients with serious hepatic disease 20. patients who are taking other fluoropyrimidine anticancer drug, or fluoropyrimidine antifungal (flucytosine) 21. evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve;Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event: Clinical laboratory test;adverse event: vital signs | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong Sook Jin
Kyungpook National University Hospital
Outcome results
None listed