Clinical Trial Details (PDF Generation Date :- Sun, 02 Sep 2018 23:38:24 GMT) CTRI Number Last Modified On 05/02/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/04/004522 [Registered on: 03/04/2014] - Trial Registered Prospectively BA/BE Other A clinical trial intended to compare two formulations of Methotrexate tablets 2.5 mg, in patients with mild to severe psoriasis or Rheumatoid Arthritis. An Open-Label, Randomized, Single-dose, Two-period, Two-treatment, Two-sequence, Crossover, Multicentre, Bioequivalence study of Methotrexate tablets 2.5 mg of Cadila Healthcare ltd., and Methotrexate tablets 2.5 mg of Dava Pharmaceuticals, USA in adult patients with mild to severe Psoriasis or Rheumatoid Arthritis under fasting conditions. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CRL121318, Version 1.0, Dated 25 Dec 2013 Designation Affiliation Protocol Number Details of Principal Investigator Dr Charu Gautam Phone 07966135655 Fax 07966135641 Email Designation Affiliation Associate VP-Global Clinical Operation Cliantha Research Limited Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower, Near Judges Bungalow Road, Bodakdev, Ahmedabad, Gujarat,, 380054 cgautam@clianthatrials.com Details Contact Person (Scientific Query) Dr Charu Gautam Phone 07966135655 Fax 07966135641 Email Designation Affiliation Associate VP-Global Clinical Operation Cliantha Research Limited Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower, Near Judges Bungalow Road, Bodakdev, Ahmedabad, Gujarat,, 380054 cgautam@clianthatrials.com Details Contact Person (Public Query) Dr Chirag Shah Head- Clinical Trials Cliantha Research Limited Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone 07966135631 Fax 07966135641 Email > Cadila Healthcare limited Type of Sponsor Cliantha Research Limited List of Countries of Principal Investigator Dr Arvind Chopra Gujarat. Cliantha House, Opp. Pushparaj Tower, Near Judges Bungalow Road, Bodakdev, Ahmedabad, Gujarat,, 380054 cshah@clianthatrials.com Source of Monetary or Material Support Primary Sponsor Details Cadila Healthcare limited Sarkhej Bavla N.H..8A, Moraiya, Tal: Sanand, Dist: Ahmedabad 382 210, Gujarat,. Pharmaceutical industry-n Cliantha Research Limited, Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower, Near Judges Bungalow Road, Bodakdev, Ahmedabad, Gujarat,, - 380054. of Site Site Phone/Fax/Email Centre for Rheumatic Disease Dr Parag Gopal Kalyani Grant Medical Foundation, Ruby Hall Clinic Dr Pradhyuman Prakash Vaidya Jahangir Clinical Development Centre Pvt. Ltd. Orthopedics, Centre for Rheumatic Disease, 11 Hermes Elegance, 1988 Convent Street, Camp, Pune 411 001, Maharashtra Pune MAHARASHTRA Dermatology, Grant Medical Foundation, Ruby Hall Clinic, 40, Sassoon Road, Pune 411001, Maharashtra Pune MAHARASHTRA Dermatology,Jahangir Clinical Development Centre Pvt. Ltd., Jahangir Hospital premises, 32 Sassoon Road, Pune-411001, Maharashtra Pune MAHARASHTRA 912026344099 9120-26350084 crdp@vsnl.net 919822284447 912066455628 parag.kalyani@yahoo.c om 9822400964 02026059319 drpvaidya@gmail.com page 2 / 6
Details of Ethics Committee Dr Laxmikant Goyal Dr Bankimchandra Nanubhai Desai Malpani Multispecialty Hospital Nirmal Hospital Private ltd Orthopedics, Malpani Multispecialty Hospital, SP 6, Road. 1, VKI Area, Sikar Road, Jaipur-302013, Rajasthan Jaipur RAJASTHAN Orthopedics,Nirmal Hospital Private ltd, Ring Road, Civil street, Near Kadiwala school, Surat 395002, Gujarat Surat Dr Gaurav Rathi Rathi Hospital Orthopedics, Rathi Hospital, Nr. Anupam Shopping Centre, Opp. Mahabaleshwar Socity, Jodhpur cross road, Satellite, Ahmedabad 380015, Gujarat Dr Vishwanath Yaligod Dr S Rukmangatha rajan Sapthagiri Institute of Medical Sciences and Research Center Sri Ramachandra Medical centre 919462651019 911412333886 drlkgoyal@gmail.com 919825136077 912612313638 drbankim.desai@gmail. com 919824015618 drgjrathi@yahoo.co.in 919342405896 Orthopedics, Sapthagiri 9180-22188737 Institute of Medical vvyaligod@gmail.com Sciences and Research Center,. 15, Chikkasandra, Hesaraghatta Main Road, Bangalore-560090, Karnataka Bangalore KARNATAKA 919444120808 Orthopedics, Sri Ramachandra Medical dr.srukmangatharajan centre, -1 @yahoo.com Ramchandra Nagar, Porur, Chennai-600116, Tamilnadu Chennai TAMIL NADU of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee - Jahangir Clinical Development Centre Pvt. Ltd. Committee - Nirmal Hospital Private ltd Committee - Rathi Date Specified Date Specified Approved 22/02/2014 page 3 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Ethics Committee Committee - Sapthagiri Institute of Medical Sciences and Research Center Approved 20/02/2014 Committee -CRD Ethics Committee Committee, Sri Ramachandra University & Hospital Committee- Malpani Multispecialty Hospital Committee- Poona Medical Research Foundation Status Date Specified Date Specified Approved 01/03/2014 Date Specified Date Approved/Obtained 19/03/2014 Health Type Patients Condition Mild to Severe Psoriasis or Rheumatoid Arthritis Type Details Intervention Comparator Agent Age From Age To Gender Methotrexate tablets 2.5 mg, manufacture by Cadila Healthcare Limited. Methotrexate tablets 2.5 mg, manufacture by Dava Pharmaceuticals, USA 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria Each patient will be administered one dose methotrexate in first day of either on period I or Period II. Each patient will be administered one dose methotrexate in first day of either on period I or Period II. Details 1. Males or non pregnant, non lactating females between 18-65 years of age (both inclusive). 2. Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18. 3. Patients with mild to severe Psoriasis or Rheumatoid Arthritis who are receiving methotrexate 2.5 mg orally every 12 hours for 3 doses 4. Able to give written informed consent to participate in the study 5. All patients should be judged eligible by the principal investigator or co-investigator or physician during a pre-study safety assessment performed within 21 days of the first dose of study medication Details Exclusion Criteria 1. History of allergic responses to Methotrexate or other related drugs or any of its formulation ingredients. 2. Liver dysfunction or Renal dysfunction 3. Patients suffering from alcoholic liver disease or chronic liver disease or receiving other potential hepatotoxic drugs 4. Patients who have pre-existing blood dyscrasias, such as bone page 4 / 6
Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization An Open list of random numbers Open Label marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia 5. Patients currently suffering from or having a history of malignant lymphoma or tumor lysis syndrome 6. Patients suffering from any acute infection within two weeks prior to randomization. 7. Patients suffering from lung disease or skin reactions due to methotrexate. 8. Participation in any investigational drug study within 30 days prior to randomization. Primary Outcome Outcome Timepoints Pharmacokinetic parameters Cmax, AUC24, AUCt and Tmax In each period, The pre-dose blood sample on Day 1, will be collected 8.0 ml within 30 minutes before dosing time and 4 ml after dosing at At 0.167, 0.33, 0.50, 0.67,0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00 and 12.00 hours. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary To monitor the adverse events and to ensure the safety of Patient Total Sample Size=32 Sample Size from =32 N/A 08/04/2014 Date Specified Years=1 Months=0 Days=0 t Applicable Completed All patients with Psoriasis or Rheumatoid Arthritis will be housed in the clinic in each period. Single oral dose of either the test product or reference product will be administered in the morning as per the randomization schedule on Day 01 in each period. Restriction: Fasting for at least 10 hours prior to dosing to at least 04 hours post-dose of dosing day (day 01) in each period. Water will be restricted (at least) from 01 hour before dosing until 01 hour after dosing (no fluid, except for water given with dosing) in each period. Patients will remain seated upright for initial 04 hours post-dose on dosing day 01 NA page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial in each period and only necessary movement will be allowed during this period. Blood Sample: In each period, total of 21 blood samples will be collected. page 6 / 6