A Study of Methotrexate Tablets 2.5 mg in Adult Patients with Inflammatory Disorder of many joints and/or Patches of Abnormal Ski
- Conditions
- Health Condition 1: M069- Rheumatoid arthritis, unspecified
- Registration Number
- CTRI/2018/11/016245
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
1. Male and female patient with age of 18 to 65 years (both inclusive)
2. Body mass index (BMI) between 18.5 and 30 kg per meter square (both inclusive)
3. Patients with active rheumatoid arthritis diagnosed according to the revised 2010 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis or patients of psoriasis who are receiving methotrexate therapy.
4. Patients must be on an established dose of methotrexate 2.5 mg 12 hourly for 3 doses per week for greater than or equal to 28 days prior to screening
5. Patient meets the ACR 1991 revised criteria for RA Global Functional Status I or II
6. Patient on other medications (excluding MTX) for the treatment of RA should have discontinued these medications at least 28 days or 5 halflives of the drug (whichever is longer) before screening
7. Patient screening laboratory assessment are clinically non significant as per the discretion of the Investigator
8. No history of addiction to any recreational drug or drug dependence
9. No participation in any clinical study within the past 60 days prior to receiving the first dose of investigational product for the current study
10. Patient must be able to give informed consent for participation in the trial
11. Female patients of child bearing potential must agree to use an effective method of contraception during the study and for a minimum of 1 month after therapy.
12. Male patients must agree to use a male condom throughout the study and for a minimum of 3 months after the end of therapy.
13. Serum pregnancy test at screening and urine pregnancy test at check-in must be negative for female patients
1. A history of allergic or adverse reactions to Methotrexate Sodium or any related drug or any excipient of methotrexate tablets
2. Patients with presence of any neoplasm or with past history of any neoplasm
3. Patients who have pre-existing hematopoietic impairment/ blood dyscrasias, such as bone marrow hypoplasia, aplastic anemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia and or significant anemia
4. Patient with lymphadenopathy and lymphoproliferative disorders
5. Patients suffering from any acute infection within two weeks prior to randomization
6. Patients with history of tumor lysis syndrome.
7. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
8. History of difficulty with donating blood or difficulty in accessibility of veins
9. Patient with liver enzyme test abnormalities, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total
bilirubin greater than 2 times the upper limit of normal (ULN)
10. Patient has a recent history (within the last 6 months) of drug or alcohol abuse (as defined by the Investigator) or a positive urine screen for alcohol or drugs of abuse/illegal drugs at screening or check-in
11. Patients with presence or previous history of clinically significant systemic disease which might confound the results of the study or pose an additional risk in administering study drug(s) to the patient at the discretion of investigator. This may include, but not be limited to, a history of drug or food allergies, uncompensated heart failure,
uncontrolled diabetes mellitus, severe hepatic failure, severe pulmonary disease, or history of mental disease and patients with alcoholic liver disease or other chronic liver disease.
12. Patients with significant abnormal laboratory values at screening including ECG and X-ray
13. Patients for whom oral administration of drug is not possible
14. Patients who have overt or laboratory evidence of immunodeficiency
syndromes
15. Patients with positive HIV, Hepatitis B or Hepatitis C test at the time
of screening
16. Pregnant women and Nursing (lactating) mothers
17. Donation of blood (1 unit or 350 mL) within 90 days prior to receiving
the first dose of study medicine
18. Expected changes in concomitant medications during the period of
study
19. Patients for whom oral administration of drug is not possible
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the pharmacokinetic profile and to prove bioequivalence of test formulation in comparison with reference <br/ ><br>formulation.Timepoint: Pre-dose and <br/ ><br>at 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, 5.000, 6.000, 8.000, 10.000 and 12.000 hours post dose
- Secondary Outcome Measures
Name Time Method Safety of the patients exposed to the Investigational <br/ ><br>Medicinal Product.Timepoint: Entire duration of Study