Health Condition 1: C162- Malignant neoplasm of body of stomach
Conditions
Interventions
Intervention1: FDC of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg capsule: FDC of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil
15.8 mg capsule
Manufactured by: BDR Pharmaceuticals Internat
Sponsors
BDR Pharmaceuticals Internationals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Teysuno, (containing Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg) capsule (Reference formulation) Marketed by: Novodic Group BV, Nederland
Exclusion criteria
Exclusion criteria: 1. History of severe and unexpected reactions to fluoropyrimidine therapy 2. History of allergic reaction to heparin. 3. Subjects with history of severe bone marrow depression. 4. Subjects with end stage renal disease requiring dialysis 5. Subjects undergone treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine 6. History of any other chemotherapeutic treatment within 5 weeks prior to first administration of the drug. 7. Subjects within six months after subtotal gastrectomy, or patients with total gastrectomy, or patients with frequent relapse of peptic ulcer. 8. History of other surgery within four weeks prior to the first administration of the study drug. 9. History of radiotherapy within six weeks prior to the first administration of the study drug. 10. Evidence of metastases to other organs (brain or bone, etc.) other than gastric cancer. 11. Subjects with active infectious disease (any febrile disease with fever >38°C);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. Male subjects not ready to use effective contraception and female subjects of child-bearing potential not ready to use effective contraception or who are pregnant or nursing. 13. Systolic blood pressure less than 90 mmHg or more than 140 mmHg and Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator. 14. Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening. 15. Respiratory rate below 15 or above 20 breaths per minute. 16. Oral temperature below 96.2o F or above 99.8 o F at the time of screening. 17. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period. 18. Existence of any surgical or medical condition which in judgement of investigator, might interfere with the absorption, distribution, metabolism and elimination of the drug or likely to compromise the safety of the subject. 19. The presence of clinically significant abnormal physical findings, laboratory values, ECG findings, and or any other clinical observations or history during screening which would interfere with the objective of the study. 20. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis. 21. A history of difficulty with giving blood. 22. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study. 23. Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes which may interact with the treatment within 14 days prior to IP administration. 24. Subjects using anticoagulants 25. Subjects with any clinically s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tegafur, gimeracil, oteracl and 5-fluorouracil.: Cmax, AUC0-t, AUC0-inf.Timepoint: Predose and at 0.17, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post drug administration in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tegafur, gimeracil, oteracil and 5-fluorouracil.: tmax, Kel,, thalf, AUC% Extra_obs.Timepoint: Predose and at 0.17, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post drug administration in each period. | — |
Countries
India
Contacts
Public ContactDr Smitha Saldhana
Notrox Research Private limited
Outcome results
None listed