CTRI/2014/08/004909 [Registered on: 21/08/2014] Trial Registered Retrospectively
Last Modified On:
25/10/2016
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A two stage, randomized, multicentric, open-label, multiple dose, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of test Nilutamide 150 Mg tablets with reference Nilandron 150 mg tablets
Scientific Title of Study
A two stage, randomized, multicentric, open-label, multiple dose, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of test Nilutamide 150 Mg tablets (from EirGen Pharma Ltd.,Ireland) with reference Nilandron 150 mg tablets of Sanofi-aventis U.S. LLC in prostate cancer patients under fasting condition.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
RLS/0314/020, Version 01 dated 5th May 2014
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Head-Medical Affair & PV
Affiliation
Reiance Life Sciences Pvt.Ltd
Address
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra , India
Thane MAHARASHTRA 400701 India
Phone
91-22-67678208
Fax
91-22-67678242
Email
pravin.ghadge@relbio.com
Details of Contact Person Scientific Query
Name
Dr Pravin Ghadge
Designation
Head-Medical Affair & PV
Affiliation
Reiance Life Sciences Pvt.Ltd
Address
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra , India
Thane MAHARASHTRA 400701 India
Phone
91-22-67678208
Fax
91-22-67678242
Email
pravin.ghadge@relbio.com
Details of Contact Person Public Query
Name
Dr Sanjeev Hegde
Designation
Head-Clinical Development
Affiliation
Reliance Life Sciences Pvt.Ltd
Address
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra , India.
Thane MAHARASHTRA 400701 India
Phone
91-22-67678208
Fax
91-22-67678242
Email
Sanjeev.hegde@relbio.com
Source of Monetary or Material Support
EirGen Pharma Ltd
Primary Sponsor
Name
EirGen Pharma Ltd
Address
Westside Business Park, Waterford, Ireland
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Reliance Life Sciences PvtLtd
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.
Opp. Mahamarg bus stand, Mumbai Naka, Nashik 422004, Maharashtra, India. Nashik MAHARASHTRA
9970184510
drtejashree@mcrinasik.com
Dr RaghunathSK
HCG Bangalore Institute of Oncology, Bangalore
HCG- bangalore institute of Oncology, HCG Towers, Tower I,1st floor, Room No. 8, P. Kalinga rao Road, Sampangiram Nagar, Bangalore-560027, India Bangalore KARNATAKA
080-40206000
deraghunathsk@yahoo.com
Dr Bhalchandra Kashyapi
Jehangir Clinical Development Centre Pvt. Ltd., Pune
Consultant Onco-Urologist, Jehangir Clinical Development Centre Pvt. Ltd. Jehangir Hospital Premises,Building Basement ONCO OPD 32 Sassoon Road,Pune-411001, Maharashtra, India Pune MAHARASHTRA
9822406084
kashyapi1@gmail.com
Dr Jyothi N
Karnataka Cancer Hospital, Bangalore
Karnataka Cancer Hospital, 1st Floor #99 Jharakabande, Krishanananda Nagar, Nandini Layout Post(Near Kanteerava Studio), Bangalore – 560096, India Bangalore KARNATAKA
9448051964
jyothichinnali@yahoo.com
Dr Sagar Bhalerao
Lifepoint multispecialty hospital
Lifepoint multispecialty hospital,145/1, Mumbai Banglore highway,Near hotel Sayagi, Wakad, Pune - 411057. Pune MAHARASHTRA
9422185735
bhalerao.sagar119@gmail.com
Dr Vikram Gota
Tata Memorial Centre, Kharghar
Department of Clinical Pharmacology,
1st Floor, Room No: KS102 Advanced Centre for Treatment Research And Education in Cancer(ACTREC), Tata Memorial Centre, Kharghar,
Navimumbai-410210, Maharashtra,India Thane MAHARASHTRA
Ethics committee Jehangir Clinical Development Centre Pvt. Ltd. Jehangir Hospital Premises, 32 Sassoon Road,Pune-411001, Maharashtra, India
Approved
HCG-Central Ethics Committee,HCG-banglore Institute of Oncology, HCG Towers,Tower I,1st floor,No. 8, P. Kalinga Rao Road, Sampangiram, Nagar,Banglore, 560027, India
Approved
IEC, Clinical research secretarieant, 3rd Floor, Main Bldg. Tata memorial hospital, Dr. E. Borges road, Parel Mumbai-400012, India
Approved
Institutional Ethics Committee, Karnataka Cancer Hospital & Research Centre, #99 Jharakabande, Krishanananda Nagar, Nandini Layout Post, Bangalore – 560096, India
Approved
Jasleen Hospitals Ethics Committee,Opposite to Big Bazar,Panchshil Square,Dhantoli, Nagpur -440012
Manavata Clinical Research Institute, Ethics Committee, Opposite Mahamarge Bus stand, Mumbai Naka, Nasik 422004
Approved
Poona Medical Research Foundation,Institution Ethics Committee, E4 C to E4 F , 4th floor, Fifth Avenue, Condomonium, Dhole Patil Road,Pune -411001
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Prostate cancer patients,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Nilandron 150 mg tablets
Oral administration, under fasting condition, multiple dose. OD dose of 150 mg tablet of Nilutamide (Test/Reference) will be given for (4 weeks during stabilization phase, followed by 4 weeks during the maintenance phase post randomization, 2 days during each of the 2 PK phases and for 4 weeks during the post study safety follow-up phase).
Intervention
Nilutamide 150 Mg tablets
Oral administration under fasting condition, multiple dose.OD dose of 150 mg tablet of Nilutamide (Test/Reference) will be given for (4 weeks during stabilization phase, followed by 4 weeks during the maintenance phase post randomization, 2 days during each of the 2 PK phases and for 4 weeks during the post study safety follow-up phase).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
Inclusion Criteria
1. Adult patients suffering from prostate cancer; aged between 18 to 70 years.
2. Patients with histologically confirmed prostate cancer not amenable to curative therapy with surgery or radiation, and had evidence of progressive disease despite treatment with adequate hormonal therapy, as defined by continued treatment with an LHRH agonist or previous orchidectomy, and after treatment with either/or both flutamide or bicalutamide
3. Patients willing to voluntarily provide written informed consent.
4. Patients willing to undergo pre and post-study physical examinations and laboratory investigations.
5. Eastern Cooperative Oncology Group performance status of 0–2
6. Patients willing to adhere to protocol and they should not consume coffee, tea, chocolate, grape fruit juice or soft drink at least 24 hours prior to investigational product administration (i.e. in-house monitoring and the remaining based on history) and during their clinical stay in each study period.
7. Patient should be willing to adhere to the protocol and they should not consume alcohol at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and should agree not to take any amount of alcohol during the study period.
8. Patients able and willing to comply with the protocol requirements.
ExclusionCriteria
Details
Exclusion Criteria
1. Patients incapable of understanding the informed consent process.
2. Patients with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study
3. Patients with evidence of psychiatric disorder likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
4. Patients with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.
5. Any treatment which could affect the pharmacokinetic of Nilutamide/known interactions
6. Patients with a known history of drug hypersensitivity to nilutamide or any excipients of the formulation.
7. Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and with history of drug abuse, found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates).
8. Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus reactive/positive.
9. Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit
10. Patients who, have clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen, (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), c-glutamyltranspeptidase, serum bilirubin, serum glucose (fasting) etc.
11. Patients with clinically significant abnormal urine analysis, defined as the presence of RBC (5/HPF), pus cells (5/HPF), epithelial cells (5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive).
12. Patients with a clinically significant past history or current medical condition of:
• Pulmonary disorders (COPD and asthma)
• Cardiovascular disorders (especially cardiac blocks)
• Neurological disorders (especially seizures, migraine)
• Renal and/or hepatic disorders
• Visual abnormality
13. Patients who have participated in any other clinical investigation or have bled more than 300 ml in the past 3 months.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Bioequivalence of the two formulations (T vs R) in relation to the:
Rate of absorption
Extent of absorption
Bioequivalence of the two formulations (T vs R) in relation to the:
Rate of absorption
Extent of absorption
Secondary Outcome
Outcome
TimePoints
To monitor all the adverse events, including laboratory parameters
Assessment of thepharmacokinetic parameters
Target Sample Size
Total Sample Size="20" Sample Size from India="20" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
The study is designed as two stage, randomized, multicentric, open-label, multiple dose, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of test Nilutamide 150 Mg tablets (from EirGen Pharma