Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C189- Malignant neoplasm of colon, unspecified Health Condition 3: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: Capecitabine Tablets 500 mg: Administration of multiple units of 500 mg of capecitabine tablet as a single dose according to body surface area in each period
Control Intervention1: Xelo
Sponsors
Healthcare Pharmaceuticals Limited
SpinoS Lifescience And Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide voluntary informed consent and able to comply with protocol requirements Male or Female aged 18 to 65 years both inclusive having body mass index BMI at least 17 00 calculated as weight in kg per height in m2 Patients having Body Surface Area between 1 27 to 1 92 m2 both inclusive measured as per the Dubois formula Patients with histopathologically or cytologically confirmed colon or colorectal or breast or Gastric cancer 5Patients already receiving a stable twice-daily dosing regimen as prescribed by the reference product label ie 1250 mg Per m2 twice daily equivalent to 2500 mg/m2 total daily dose for two weeks followed by a one-week rest period given as three week cycles Acceptable hematology status Hemoglobin greater or equal to 9 g per dL Absolute neutrophil count ANC greater or equal to 1500 cells per mm3 Willing and able to provide voluntary informed consent and able to comply with protocol requirements Male or Female aged 18 to 65 years both inclusive having body mass index BMI at least 17 00 calculated as weight in kg per height in m2 Patients having Body Surface Area between 1 27 to 1 92 m2 both inclusive measured as per the Dubois formula Patients with histopathologically or cytologically confirmed colon or colorectal or breast or Gastric cancer Patients already receiving a stable twice daily dosing regimen as prescribed by the reference product label i e 1250 mg/m2 twice daily equivalent to 2500 mg/m2 total daily dose for two-weeks followed by a one-week rest period given as three week cycles Acceptable hematology status Hemoglobin greater or equal to 9 g per dL Absolute neutrophil count ANC greater or equal to 1500 cells per mm3 Platelet count greater or equal to 100000 cells per mm3 Acceptable liver function Alanine aminotransferase ALT less than or equal to 2 5 X ULN Aspartate aminotransferase AST less than or equal to 2 5 X ULN Bilirubin less than or equal to 1 5 X ULN Alkaline phosphatase less than or equal to 2 5 X ULN Patients with creatinine clearance greater than 60 mL per minute Patients with life expectancy of at least 3 months at the time of enrollment Non smokers and non alcoholics Male patients must agree to use an effective method of contraception from screening during study and for at least 03 months after treatment discontinuation Female patients with negative serum pregnancy test at screening and negative urine pregnancy test on Day 00 Women of child bearing potential defined as women physiologically capable of becoming pregnant unless they are using effective method of contraception during dosing of the investigational product practicing two acceptable methods of contraception
Exclusion criteria
Exclusion criteria: Known hypersensitivity or contraindication to fluoropyrimidine therapy or to any of the components of investigational product Known hypersensitivity or contraindication to Capecitabine Known CNS metastasis Known deficiency of dihydropyrimidine dehydrogenase DPD Patient with history of cardiac disease Major surgical procedure including periodontal within 28 days of first dose of Investigational Product Surgical or other non-healing wounds Patients with positive serology for Hepatitis B Virus HBV Hepatitis C Virus HCV or Human Immunodeficiency Virus HIV Patients with positive urine screen for drugs of abuse History of other malignancies in the last 5 years except in situ cancer or basal or squamous cell skin cancer Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product Loss of blood greater or equal to 350 mL within 90 days prior to receiving the first dose of investigational product for the current study Patients taking or scheduled to receive any of the Cytochrome P450 2C9 substrates Any other medical condition or uncontrolled systemic disease cardiovascular disease hypertension diabetes mellitus etc that in the opinion of the Investigator may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness social situations that would limit adherence to study requirements Lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of Capecitabine Tablets 500 mg in patients with Breast Cancer or Colon Cancer or Gastric Cancer or Colorectal Cancer under fed conditionTimepoint: 17 blood samples 00 00 Hrs 00 25 Hrs 00 50 Hrs 00 75 Hrs 01 00 Hrs 01 25 Hrs 01 50 Hrs 01 75 Hrs 02 00 Hrs 02 33 Hrs 02 67 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 06 00 Hrs and 08 00 Hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability in Breast Cancer or Colon Cancer or Gastric Cancer or Colorectal Cancer patients under fed conditionsTimepoint: 17 blood samples 00 00 Hrs 00 25 Hrs 00 50 Hrs 00 75 Hrs 01 00 Hrs 01 25 Hrs 01 50 Hrs 01 75 Hrs 02 00 Hrs 02 33 Hrs 02 67 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 06 00 Hrs and 08 00 Hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spino Life science and research private limited
Outcome results
None listed