REF/2015/04/ CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Sun, 13 May :38:30 GMT) CTRI Number Last Modified On 27/04/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/05/ [Registered on: 05/05/2015] - Trial Registered Prospectively BA/BE Randomized, Crossover Trial To compare bioavailibility of Methotrexate Tablets 2.5 mg( Actavis LLC) with Methotrexate Tablets USP 2.5 mg (DAVA Pharmaceuticals, Inc.USA) in patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours under fasting condition. A multicenter, randomized, open label, two treatment, two period, two sequence, single-dose, crossover, bioequivalence study of Methotrexate Tablets 2.5 mg (manufactured for Actavis LLC) with Methotrexate Tablets USP 2.5 mg (DAVA Pharmaceuticals, Inc., Fort Lee, NJ USA) in patients with mild to severe psoriasis or rheumatoid arthritis (RA), who are already on established regimens of 2.5 mg every 12 hours under fasting condition. 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) 14-VIN-721 Version 01 dated 17 Dec 2014 Designation Affiliation Protocol Number Details of Principal Investigator Dr Ashoka Kumar Singh Head of Department Phone Fax Designation Affiliation Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway. Ahmedabad Ashoka.Singh@veedacr.com Details Contact Person (Scientific Query) Dr Ashoka Kumar Singh Head of Department Phone Fax Designation Affiliation Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway. Ahmedabad Ashoka.Singh@veedacr.com Details Contact Person (Public Query) Dr Ashoka Kumar Singh Head of Department Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway. Ahmedabad page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Actavis LLC Type of Sponsor NIL List of Countries of Principal Investigator Source of Monetary or Material Support Actavis LLC Primary Sponsor Details Actavis LLC Morris Corporate Center III,400 Interpace Parkway Parsippany, NJ Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Dr Siva G Prasad Apollo Hospitals Waltair main road, Vizag Visakhapatnam ANDHRA PRADESH Dr Kalpesh Mehta B. J. Medical collage and Civil Hospital Orthopedic Department, Asarwa, Ahmedabad , Gujarat Dr Sharmila Patil D. Y. Patil Hospital Department of dermatology, OPD.: 54, 1st floor Nerul, New mumbai Mumbai Dr Mukesh Sancheti DrSomesh Singh Dr Sajal Mitra Ganga CARE Hospital Limited GMERS Medical Collage & Civil Hospital Sola Govt. Medical College & Hospital Department Of Orthopedics, 3 Farmland Panchsheel square, Ramdaspeth, Nagpur Nagpur Department Of Orthopedics, Near Gujarat High Court, SG highway, Sola,Ahmeda bad Department of Orthopedic, Medical Square, Nagpur dr_sivaji@yahoo.co.in drkaps@rediffmail.com drsharmilapatil@gmail.c om mksancheti@gmail.com drsomeshsingh@yahoo.com sajalmitra2007@yahoo. co.in page 2 / 7

3 Dr Pradyumna Vaidya Jahangir Clinical Development Centre Pvt. Ltd Nagpur Jahangir hospital Premises, 32 Sasoon road, Pune Pune Dr M Pradha Saradhi King George Hospital Department Of Orthopedics, King George Hospital, Visakhapatnam , A.P. Visakhapatnam ANDHRA PRADESH Dr Laxmikant Goyal Malpani Multi Speciality Hospital orthopedic OPD,SP-6, Road. 1, V.K.I. Are, Sikar road, Jaipur Jaipur RAJASTHAN Dr Harish Mathur Mavens Hospital Department Of Orthopedics, N-37, Vaishalinagar, Ajmer, Rajasthan Ajmer RAJASTHAN Dr Sushil Haridas Mankar DrTSudheer N K P Salve Institute of Medical Sciences & Lata Mangeshkar Hospital Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Orthopedic department, Digdoh Hills Hingna road, Nagpur Nagpur Department of Orthopedics, Research wing 2nd floor, Beside FM ward. Srikakulam Srikakulam ANDHRA PRADESH Dr Gaurav Rathi Rathi Hospital orthopedic OPD, Near Anupam Shopping Centre, Opp. Mahabaleswar society, Nr. Jodhpur cross road, Satelite, Ahmedabad Dr Ruchir Shah Dr Ravindra Wadhawan Saviour Multispecialty Hospital Sanjivani Orthopedic OPD, 1 Superspeciality Hospital Uday Park Society, Pvt. Ltd. Nr.Sunrise park, Vastrapur, Ahmedabad Orthopedic OPD, Nr Bharat Petroleum, Nr.Lakhudi Talav, Stadium road, Navrangpura, drpvaidya@gmail.com amcorthopaedics@hot mail.com drlkgoyal@gmail.com drharishmathur@yahoo.com drshmankar@rediffmail. com rimsresearch@gmail.co m drgjrathi@yahoo.co.in drruchirshah.dermatolo gist@gmail.com raviwadhawan2000@ya hoo.com page 3 / 7

4 Details of Ethics Dr Harshal Kalaria Shree Giriraj Multispeciality Hospital Ahmedabad Navjyot Park Corner, 150 Feet ring road, Rajkot Rajkot om of Approval Status Date of Approval Is Independent Ethics? Care Hospital Ethics Apollo Hospital Jahangir Clinical Development Centre Pvt. Ltd. Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital B.J. Medical College & Civil Hospital Department of Pharmacology Govt Medical College G.M.E.R.S. Medical College King George Hospital Malpani Multispeciality Hospital NKP Salve Institute of Medical Sciences & Lata Mangeshkar Hospital Approved 27/05/2015 Approved 29/06/2015 Approved 20/04/2015 Approved 19/05/2015 committee Padamshree Dr. D.Y. Patil Medical College & Hospital and Research Centre MAVENS Institutional Approved 23/06/2015 Rathi Approved 06/06/2015 Sanjivani Hospital Saviour Hospital Ethics Approved 03/06/2015 Approved 06/06/2015 page 4 / 7

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Shree Giriraj Hospital Research Ethics Status Approved 30/05/2015 Date Objection Certificate 10/04/2015 Health Type Patients Condition mild to severe psoriasis or rheumatoid arthritis Type Details Intervention Methotrexate Tablets 2.5 mg (Actavis LLC)) Comparator Agent Methotrexate Tablets USP 2.5 mg (DAVA Pharmaceuticals ) Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria On day 1 of each period, each patient would receive their dose of Methotrexate 2.5 using either the test or reference product in a crossover design. Two subsequent doses will be of locally approved drug at every 12 hrs of interval after the administration of study drug on day 1. On day 1 of each period, each patient would receive their dose of Methotrexate 2.5 using either the test or reference product in a crossover design. Two subsequent doses will be of locally approved drug at every 12 hrs of interval after the administration of study drug on day Men or Women, in between 18 to 65 years of age (both inclusive). 2.Ability to provide informed consent prior to participation in the study 3. Patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mgevery 12 hours (7.5 mg per week in three divided doses). 4.Confirmed diagnosis of psoriasis by clinical examination.or Confirmed diagnosis of mild to severe rheumatoid arthritis based on at least 1 of the following: i. Documented history of positive rheumatoid factor ii. Current presence of rheumatoid factor iii. Radiographic erosion within 12 months prior to enrolment iv. Presence of serum anti-cyclic citrullinated peptideantibodies (anti-ccp). 5. Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception. 6.Patient s screening laboratory assessment (complete blood count and blood chemistries) are clinically nonsignificant as per the discretion of the Investigator. 7. history of addiction to any recreational drug or drug dependence. 8. participation in any clinical study within the past 60 days. Exclusion Criteria 1.A history of allergic or adverse reactions to Methotraxate Sodium page 5 / 7

6 Method of Generating Random Sequence Method of Computer generated randomization t Applicable or any comparable or similar product 2. Patients with alcoholism, alcoholic liver disease or other chronic liver disease. 3.Patients who have overt or laboratory evidence of immunodeficiency syndromes. 4.Patients who have pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia 5. Expected changes in concomitant medications during the period of study 6.Tested positive for Alcohol breath or Urine drug of abuse. 7.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 for 3 months (for males) and for at least one ovulatory cycle (for females) after last dose of study medication, Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery,patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV, Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. 8.History of difficulty with donating blood or difficulty in accessibility of veins. 9. Oral Administration of Drug is not possible. 10.An unusual or abnormal diet, for whatever reason e.g.religious fasting. 11.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study. 12.Evidence of any significant uncontrolled concomitant disease which in the investigators opinion would exclude the patient participation. 13. 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 except study indication. 14. Any treatment which could affect the pharmacokinetic of methotrexate (salicylates, hypoglycaemics, diuretics,sulphonamides, diphenylhydantoins, tetracyclines,chloramphenicol and p-aminobenzoic acid, probenecid,penicillins, Chloroquine, omeprazole, etretinate, cotrimoxazole and trimethoprim etc.) administered within 1 month of starting of study. 15.Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B(HBsAg) or Hepatitis C (HCV) virus reactive/positive. 16. Patients with clinically significant abnormal haemoglobin(hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrite. 17. Patients who, have clinically significant abnormal laboratory values. 18.Patients with a clinically significant past history or current medical condition of:pulmonary disorders (COPD and asthma),cardiovascular disorders (especially cardiac blocks), Neurological disorders, GIT disorders including history or presence of significant gastric and duodenal ulceration, Renal and/or hepatic disorder coagulation disorders. 19.Endocrine disorders (especially diabetes mellitus). 20.History or presence of cancer. page 6 / 7

7 Powered by TCPDF ( REF/2015/04/ Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints The objective of this pivotal study is to compare the bioavailability of methotrexate from Methotrexate Tablets 2.5 mg (manufactured for Actavis LLC) and Methotrexate Tablets USP 2.5 mg (DAVA Pharmaceuticals,USA) in patients with mild to severe psoriasis or rheumatoid arthritis (RA), who are already on established regimens of 2.5 mg every 12 hours under fasting condition. predose sample of 3.5 ml will be collected within 5 minutes before dosing on day 1 of each period. Post dose sample of 3.5 ml each will be drawn at 0.167,0.250,0.500,0.750,1.000,1.250,1.500,1. 750,2.000,2.333,2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 7.000, 8.000, , & 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=42 Sample Size from =42 N/A 06/05/2015 Years=0 Months=6 Days=0 t Applicable Completed NA To compare and evaluate the bioequivalence study of Methotrexate Tablets 2.5 mg (manufactured for Actavis LLC) with Methotrexate Tablets USP 2.5 mg (DAVA Pharmaceuticals, Inc.,Fort Lee, NJ USA) in patients with mild to severe psoriasis or rheumatoid arthritis (RA), who are already on established regimens of 2.5 mg every 12 hours under fasting condition. Total expected duration of the study will be of at least 8 days from the day of admission of the first period till the end of study sample collection in period II. There will be at least 7 days duration between the IMP administrations in two study periods. After IMP administration in each period (on day 1), patients will be advised to receive their scheduled dose of 2.5 mg Methotrexate tablet 12 hours apart for additional 2 doses using locally approved drug. A total of 22 PK samples will be collected during each period. NA page 7 / 7