Comparative BE study of Everolimus 10 mg tablet OD manufactured by Par Pharmaceutical,NY 10977,USA with Afinitor10 mg tablet manufactured by Novartis Pharma Stein AG Stein, Switzerland in Advanced Renal Cell Carcinoma patients under fasting condition.
- Conditions
- Health Condition 1: null- Advance Renal cell carcinoma
- Registration Number
- CTRI/2014/02/004394
- Lead Sponsor
- Par PharmaceuticalInc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
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.Histologically or Cytologically confirmed diagnosis of advanced renal cell carcinoma.
4.Women of childbearing potential must have a negative serum pregnancy test in screening and negative urine pregnancy test on day 0 and must be using an adequate method of contraception.
5.Patients with advanced renal cell carcinoma and who are already receiving a stable dose of Everolimus tablets, 10 mg tablet once daily.
6.Adequate organ function, defined as the following:
•Hemoglobin level >= 9 gm /dl
•Total bilirubin < 1.5 x upper limit of normal (ULN)
•SGOT and SGPT < 2.5 x ULN
•Creatinine < 1.5 x ULN
•Platelets > 100 x 10 raise to nine/L
•Clinically non significant fasting blood glucose levels
7.No history of addiction to any recreational drug or drug dependence
8.No participation in any clinical study within the past 60 days prior to first dosing in the study.
9.ECOG performance status of <= 2 on the ECOG scale
10.Clinically acceptable ECG in opinion of the Investigator/Designee.
1.A history of allergic or adverse reactions to Everolimus or any other rapamycin derivative or any of its excipients
2.Patients with renal failure, or for whom the need for dose change during the study can be anticipated, should be excluded.
3.Patient with active infection and symptoms of Non-infectious pneumonitis (symptoms such as but not limited to hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations) as judged by the investigator.
4.Concurrent use of other drugs known to suppress bone marrow function
5.Expected changes in concomitant medications during the period of study
6.Positive tests for drug of abuse at baseline.
7.History of alcoholism / alcohol abuse.
8.Patients who are:
•Pregnant
•Breast feeding
•Of childbearing potential without a negative pregnancy test at baseline
•Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial and at least 8 week after ending study treatment.
9.Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
10.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV.
11.Patients with any significant history of non-compliance to medical regimens
12.History of difficulty with donating blood or difficulty in accessibility of veins.
13.Patients for whom oral administration of drug is not possible.
14.An unusual or abnormal diet, for whatever reason e.g. religious fasting.
15.Patients having known brain metastasis
16.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To compare and evaluate the multiple-dose oral bioavailability of Everolimus 10 mg tablet once daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977 USA, with Afinitor (Everolimus) 10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced renal cell carcinoma patients under fasting condition.Timepoint: The pre-dose blood sample of 3.0 mL (00.00) will be collected within 5 minutes before dosing on Day 12 and 14 of both periods. On day 14, the post-dose blood samples of 3.0mL each will be drawn at 0.25, 0.5,0.75, 1.0,2.5, 3.0, 4.0, 8.0, 12.0 and 24.0 hrs following drug administration in each period.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of PatientTimepoint: Not Applicable