Bioequivalence study of Capecitabine Tablets USP, 500 mg in adult human cancer patients under fed conditions.
Completed
- Conditions
- Malignant (primary) neoplasm, unspecified,
- Registration Number
- CTRI/2022/07/044491
- Lead Sponsor
- Novugen Oncology Sdn Bhd
- Brief Summary
This a An open label, multicenter, balanced, randomized,two-treatment, four-period, two-sequence, full replicate crossover, singledose, pharmacokinetic bioequivalence study of Capecitabine Tablets USP, 500 mgof Novugen Oncology Sdn. Bhd. with Xeloda® (Capecitabine) 500 mg Film-CoatedTablets manufactured by Roche Pharma AG, Germany following single oral dose of2000 mg (4 X 500 mg) in adult human cancer patients under fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Subjects will be considered eligible for the study based on the following criteria: 1.
- Willing and able to provide voluntary informed consent and able to comply with protocol requirements 2.
- Male or Female aged 18 to 65 years (both inclusive) having body mass index 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 cancer.
- Patients with DukesC colon cancer who have undergone complete resection of the primary tumor and when treatment with fluoropyrimidine therapy alone is preferred.
- Or Patients with metastatic colorectal carcinoma in whom treatment with fluoropyrimidine therapy alone is preferred.
- Or Patients with locally advanced or metastatic breast cancer, after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
- Patients requiring a daily dose of Capecitabine monotherapy and stabilized at least on one cycle of Capecitabine chemotherapy (ex.twice daily at a dose of 1250 mg per m2 for 2 weeks followed by one week rest period).
- Cardiac ejection fraction Greater than or equal to 50Percentby echocardiogram at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status Lessthan or equal to2.
- Acceptable hematology status: a.
- Hemoglobin Greater than or equal to 9 g per dL b.
- Absolute neutrophil count (ANC) Greater than or equal to 1500 cells per mm3 c.
- Platelet count Greater than or equal to 100,000 cells per mm3 d.
- WBC Greater than or equal to 3000 cells per mm3 10.
- Acceptable liver function: a.
- Alanine aminotransferase (ALT) Lessthan or equal to2.5 X ULN b.
- Aspartate aminotransferase (AST) Lessthan or equal to2.5 X ULN c.
- Bilirubin Lessthan or equal to1.5 X ULN d.
- Alkaline phosphatase Lessthan or equal to2.5 X ULN 11.
- Patients with creatinine clearance Greaterthan 60 mL pe rminute calculated as per Cockcroft and Gault Formula.
- Non-smokers 14.
- Male patients must agree to use an effective method of contraception from screening, during treatment and for at least 3 months after the last dose of capecitabine.
- Female patients with negative serum pregnancy test at screening and negative urine pregnancy test on Day 0.
- 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 during treatment and for 6 months after the last dose of capecitabine.
- Acceptable methods of contraception are a.
- Oral or parenteral (injection) or patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication b.
- Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) e.
- Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation f.
- Total abstinence partial abstinence is not acceptable.
- No history of addiction to any recreational drug or drug dependence or alcohol addiction.
Exclusion Criteria
- Subjects will be excluded from the study based on the following criteria: 1.Known hypersensitivity or contraindication to fluoropyrimidine therapy or to any of the components of investigational product.
- 2.Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 3.Known central nervous system (CNS) metastasis.
- 4.Known deficiency of dihydropyrimidine dehydrogenase (DPD) 5.Patients with history of cardiac disease 6.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- 7.Surgical or other non-healing wounds.
- 8.Patients with major mucocutaneous and dermatological abnormality.
- 9.Patients with coagulopathy.
- 10.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- 11.Patients with suspected signs and symptoms of COVID-19/confirmed novel coronavirus infection (COVID-19) or with a recent history (within 14 days) of travel/contact with any COVID-19 positive patient/isolation/quarantine.
- 12.Patients with positive urine screen for drugs of abuse.
- 13.Patients with positive urine alcohol test 14.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
- 15.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- Exceptions are alopecia (any grade is acceptable), haemoglobin Greater than or equal to 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (As per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0) 16.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
- 17.Loss of blood Greater than or equal 350 mL within 90 days prior to receiving the first dose of investigational product for the current study.
- 18.Patients taking or scheduled to receive any of the prohibited medications (as per appendix B) 19.Any other medical condition or uncontrolled systemic disease (e.g. 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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare and evaluate bioequivalence of A total of 72 blood samples will be collected during the study at 00 Hr,00.17 hr,0.33,0.50,0.67,1.0,1.25,1.50,1.75,2.0,2.33,2.67,3.0,3.50,4.0,5.0,6.0,8.0 hrs Capecitabine Tablets USP, 500 mg of Novugen Oncology Sdn. Bhd. with Xeloda® (Capecitabine) 500 mg Film-Coated Tablets A total of 72 blood samples will be collected during the study at 00 Hr,00.17 hr,0.33,0.50,0.67,1.0,1.25,1.50,1.75,2.0,2.33,2.67,3.0,3.50,4.0,5.0,6.0,8.0 hrs manufactured by Roche Pharma AG, Germany, A total of 72 blood samples will be collected during the study at 00 Hr,00.17 hr,0.33,0.50,0.67,1.0,1.25,1.50,1.75,2.0,2.33,2.67,3.0,3.50,4.0,5.0,6.0,8.0 hrs following single oral dose of 2000 mg (4 X 500 A total of 72 blood samples will be collected during the study at 00 Hr,00.17 hr,0.33,0.50,0.67,1.0,1.25,1.50,1.75,2.0,2.33,2.67,3.0,3.50,4.0,5.0,6.0,8.0 hrs conditions. A total of 72 blood samples will be collected during the study at 00 Hr,00.17 hr,0.33,0.50,0.67,1.0,1.25,1.50,1.75,2.0,2.33,2.67,3.0,3.50,4.0,5.0,6.0,8.0 hrs mg) in adult human cancer patients under fed A total of 72 blood samples will be collected during the study at 00 Hr,00.17 hr,0.33,0.50,0.67,1.0,1.25,1.50,1.75,2.0,2.33,2.67,3.0,3.50,4.0,5.0,6.0,8.0 hrs
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of patients. A total of eighteen (18) blood samples of 3.0 mL each will be collected for PK analysis in each period of the study. A total of 72 blood samples will be collected during the study.
Trial Locations
- Locations (9)
CIMETs Inamdar Multispecality Hospital
🇮🇳Pune, MAHARASHTRA, India
Erode Cancer Centre
🇮🇳Erode, TAMIL NADU, India
HCG Manavata Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
Kiran Multi Super Specialty Hospital
🇮🇳Surat, GUJARAT, India
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
🇮🇳Belgaum, KARNATAKA, India
Sanjeevani CBCC USA Cancer Centre, Raipur
🇮🇳Raipur, CHHATTISGARH, India
Sunshine Global Hospital
🇮🇳Surat, GUJARAT, India
Swami Harshankaranand Ji Hospital and Research Center
🇮🇳Varanasi, UTTAR PRADESH, India
Thanjavur Cancer Centre
🇮🇳Thanjavur, TAMIL NADU, India
CIMETs Inamdar Multispecality Hospital🇮🇳Pune, MAHARASHTRA, IndiaDr Minish JainPrincipal investigator9823133390minishjain009@gmail.com