Two treatment Bioequivalence study of Methotrexate 2.5 mg in patients with Rheumatoid Arthritis (RA).
- Conditions
- Health Condition 1: M069- Rheumatoid arthritis, unspecified
- Registration Number
- CTRI/2022/09/045447
- Lead Sponsor
- Elite Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
1.Male and female patient with age of 18-65 years (both inclusive)
2.Body mass index (BMI) between 18.5 and 30 kg/m² (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 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 >= 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 half-lives of the drug (whichever is longer) before screening.
7.No history of addiction to any recreational drug or drug dependence
8.Patient must be able to give informed consent for participation in the trial.
9.Male patients must agree to use a male condom throughout the study and for a minimum of 3 months after the end of therapy.
10.Serum pregnancy test at screening and urine pregnancy test at check-in must be negative for female patients
11.Women of child bearing potential, unless surgically sterile (with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must have negative pregnancy test at screening visit and before randomization and must agree to use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during the study and up to 6 months after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
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.History of peptic ulcer disease or ulcerative colitis, or any other gastrointestinal disorder or defect that would interfere with the absorption of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
5.Patient with lymphadenopathy and lymphoproliferative disorders
6.Patients suffering from any acute infection within two weeks prior to randomization
7.Patients with history of tumor lysis syndrome.
8.Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
9.History of difficulty with donating blood or difficulty in accessibility of veins
10.Patient with liver enzyme test abnormalities, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin > 2 times the upper limit of normal (ULN)
11.Patient positive on Breath alcohol analyzer test at the time of baseline visit.
12.Positive for drugs of abuse prior to receiving the first dose of investigational medicinal product in the study.
13.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.
14.Patients for whom oral administration of drug is not possible.
15.Patients who have overt or laboratory evidence of immunodeficiency syndromes.
16.Patients found positive for HIV, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
17.Pregnant or lactating females.
18.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.
19.Expected changes in concomitant medications during the period of study
20.Have ongoing clinically significant adverse event(s) due to prior treatments administered, as determined by the investigator.
21.In the opinion of the Investigator, the patient will not be compliant with the requirements of the study procedures.
22.Receipt of an investigational medicinal product or participation in an other drug research study within 30 Days (or 5 half-lives, whichever is longer) prior to receiving the first dose of investigational medicinal product for the current study.
Note: Elimination half-life of the study drug should be taken in to consideration for inclusion of the patient in the study.
23.Any surgical/medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the patient in case of participation in the stu
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method