Health Condition 1: null- Advanced renal cell carcinoma
Conditions
Interventions
Intervention1: Everolimus tablets, 10 mg of Biocon Limited,India.: As per the randomization schedule, either test [T] or [R] product will be administered orally to each patient (once daily) for 14 day
Sponsors
Biocon Limited India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and Women, of age in between 18 years to 65 years(both inclusive). 2. Ability to provide informed consent prior to participation in the study 3. Patients with confirmed diagnosis of advanced renal cell carcinoma who are candidates for everolimus therapy (10 mg once daily). 4. Patients already receiving a stable dose of Everolimus tablets.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindication to everolimus, other rapamycin derivatives or any excipient of everolimus tablets. 2. Any prior treatment with everolimus resulting in unacceptable toxicity. 3. Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization. 4. Patients with renal failure, Hepatic failure or for whom the need for dose change during the study can be anticipated, should be excluded. 5. Patients who are on active treatment with drugs that are known to interact with Everolimus. 6. Known brain metastasis, spinal cord compression, or carcinomatous meningitis. 7. Uncontrolled, significant intercurrent or recent illness. 8. History of administration of live vaccines within the past 4 weeks or need to administer a live vaccine within 4 weeks after the last dose of the study drug. 9. Pregnant and lactating females. 10. Patients with any factor preventing orally consuming tablet. 11. Any difficulty inaccessibility of forearm veins for cannulation or blood sampling. 12. Positive test for hepatitis B surface antigen, hepatitis C antibody, or humanimmunodeficiency virus (HIV) 1 and 2 serological test at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection. 13. Participation in another clinical trial in the last 60 days. 14. Positive tests for drug of abuse at baseline. 15. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence of Everolimus tablet, 10 mg of Biocon Limited, India vs. Afinitor® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in adult advanced renal cell carcinoma patients who are already receiving everolimus at a stable dose of 10 mg once a day as their individual therapy.Timepoint: Total 44 blood samples will be collected during the study for PK analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability profile of the study formulations.Timepoint: NA | — |
Countries
India
Contacts
Public ContactDr Ashoka Kumar Singh
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed