Bio equivalent study of Methotrexate tablet 2.5 mg of Eugia Pharma specialites Limited, India with Methotrexate tablets 2.5 mg of Dava Pharmaceuticals Inc, USA in adult patients with mild to severe Psoriasis or Rheumatoid Arthritis
- Conditions
- Health Condition 1: null- 1.Mild to Severe Psoriasis 2.Rheumatoid Arthritis
- Registration Number
- CTRI/2016/08/007152
- Lead Sponsor
- Eugia Pharma Specialities Limited A JV of Aurobindo Pharma Limited Celon Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1. Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
2. Subject aged between 18 to 65 years and of either sex and any race and should have BMI greater than or equal to 18.5 to less than or equal to 30 kg/m2
3. Diagnosed Subjects with mild to severe psoriasis (has involved body surface area (BSA) greater than or equal to 10 % and Psoriasis Area and Severity Index (PASI) greater than or equal to 10 at screening and at baseline)
or
Rheumatoid Arthritis (RA) diagnosed according to the 2010 ACR/EULAR classification criteria (mentioned in appendix 3).
4. Patient with mild to severe Psoriasis or Rheumatoid Arthritis who are receiving Methotrexate 2.5 mg orally every 12 hours for 3 doses (i.e. A total dose of 7.5 mg/week).
5. Subjects agreed to use acceptable methods of birth control as directed by study team.
6. Female subjects of childbearing potential must have a negative pregnancy test at Screening.
7. Subjects having adequate hematologic reserve at screening as per principal investigator/sub investigator assessment.
8. Subjects having adequate and stable hepatic function and renal function at screening as per principal investigator/sub investigator assessment.
9. Patients should be otherwise healthy as determined by physical examination, medical history and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
10. Patient must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
1. A female subject, who is pregnant, intends to become pregnant during the study (or within 6 months after study completion) or breast feeding.
2. Patient with fibromyalgia syndrome.
3. Treatment with any investigational drug within 3 months prior to screening.
4. History of infected joint prosthesis within the previous 5 years.
5. Patient with chronic infections like Pneumocystis carinii pneumonia.
6. History of receiving radiotherapy treatment.
7. History or evidence of hypersensitivity to Methotrexate or to Misoprostol or other prostaglandins and its ingredients.
8. History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection.
9. Patient with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines.
10. Patient diagnosed to be HIV 1 and 2 or Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
11. Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk.
12. History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin.
13. Subject is part of the staff or a family member of the staff personnel directly involved with this study.
14. History of drug abuse.
15. Patient with history of tumor lysis syndrome.
16. History of difficulty with donating blood or difficulty in swallowing the drug or difficulty in accessibility of veins.
17. Patient is under any treatment which could affect the pharmacokinetic of Methotrexate (Salicylates, Hypoglycaemics, Diuretics, Sulphonamides, Diphenylhydantoins, Tetracyclines, Chloramphenicol and P-aminobenzoic acid, Probenecid, Pencillins, chloroquine, Omeprazole, Etretinate, Co-trimoxazole and Trimethoprim etc.,) administered in past 1 month.
18. Patient is taking prescription of medications listed below:
Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin, Leflunomide, Hydroxychloroquine, Cyclosporin or Anti-tumor necrosis factor therapies within 90 days of visit 1 or treatment with Rituximab within 1 year before Visit 1.
19. High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption.
20. Patient donated blood greater than or equal to 350 mL within 90 days of screening.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC0-12: The area under the plasma concentration versus time curve, from time 0 to 12 hours, as calculated by the linear trapezoidal method. Cmax: Maximum measured plasma concentration over the time span specified.Timepoint: Day 1 and 8 at 0.00 , 0.25, 0.50, 0.75, 1.00, <br/ ><br>1.25. 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 5.00, <br/ ><br>6.00, 8.00 and 12 hours post dose
- Secondary Outcome Measures
Name Time Method Tmax: Time of the maximum measured plasma concentration. Kel: Apparent first order elimination rate constant calculated from a semi-log plot of plasma concentration versus time point. T½: The elimination or terminal half-life will be calculated as 0.693 /Kel. Safety and tolerability as assessed by reported adverse events (laboratory and clinical investigations and vital signs)Timepoint: Day 1 and 8 at 0.00 , 0.25, 0.50, 0.75, 1.00, <br/ ><br>1.25. 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 5.00, <br/ ><br>6.00, 8.00 and 12 hours post dose