A multicenter trial to characterize the rate and extent of Methotrexate absorption after oral administration and to assess the bioequivalence of the Methotrexate Tablets, USP 2.5mg
- Conditions
- Health Condition 1: M04-M04- Autoinflammatory syndromesHealth Condition 2: M04- Autoinflammatory syndromesHealth Condition 3: M00-M99- Diseases of the musculoskeletal system and connective tissueHealth Condition 4: null- mild to severe psoriasis or rheumatoid arthritis under fasting conditionsHealth Condition 5: M048- Other autoinflammatory syndromes
- Registration Number
- CTRI/2018/10/015921
- Lead Sponsor
- otus Pharmaceutical Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Patients with mild to severe psoriasis or rheumatoid arthritis and are already on established regimens of Methotrexate tablets 2.5 mg at 12 hour intervals for 3 doses given as a course once weekly.
2. Patients aged 18 to 65 years at the time of screening.
3. Patients who voluntarily agree to participate in the study and give their informed consent.
4. Patients who agree to comply with study procedures and the schedule of clinical and follow-up visit.
5. Patients who agree to comply with study specific restrictions and prohibitions.
6. Normal or clinically acceptable findings during screening, medical history, medical examination, laboratory evaluations (Haemoglobin value more than or equal to 10 g/dL), 12 lead ECG and X-ray chestpostero-anterior view recordings.
7. Female patients of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years), in additionto having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study.
1. Patients with known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2. Patients with history of allergic reaction to heparin.
3. Patients who had a significant surgery within 2 weeks prior to enrolling in study and as per the investigator, their inclusion may affect the
objective of the study.
4. Patients with any uncontrolled medical problem e.g. heart, lung disease or clinically significant abnormal laboratory values that in the opinion
of the investigator would preclude safe administration of the study drug.
5. Patients with clinically unacceptable abnormal laboratory values during screening.
6. Patients with history or presence gastrointestinal ulceration, bleeding and/or perforation.
7. Patients with preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia.
8. Patients with overt or laboratory evidence of immunodeficiency syndromes.
9. Patients with history or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietic, renal,
hepatic, endocrine, pulmonary, central nervous, cardiovascular, gastrointestinal or any other body system.
10. Patients with any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
11. Patients with kidney dysfunction/renal impairment.
12. Patients with ascites and pleural effusion.
13. Patients with history or presence of cancer.
14. Patients with Coagulation disorders.
15. Patients with uncontrolled diabetes mellitus and hypertension.
16. Patient with recent history of alcoholism ( <2 years) or daily consumption of alcohol or alcoholic products, alcoholic liver disease or
other chronic liver disease.
17. Patients who are current smokers, who smoke 10 or more cigarettes/day.
18. Patients with history of current or previous use of any recreational drugs or history of drug addiction.
19. Patients with history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
20. Patient who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
21. Patients with difficulty in swallowing capsule/tablet.
22. Patients who are positive for HIV, VDRL/RPR, Hepatitis B and C tests.
23. Female patients demonstrating a positive pregnancy screen or currently breast-feeding.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method