Health Condition 1: M04-M04- Autoinflammatory syndromes Health Condition 2: M04- Autoinflammatory syndromes Health Condition 3: M00-M99- Diseases of the musculoskeletal system and connective tissue Health Condition 4: null- mild to severe psoriasis or rheumatoid arthritis under fasting conditions Health Condition 5: M048- Other autoinflammatory syndromes
Conditions
Interventions
Intervention1: Methotrexate Tablets
: single dose of Methotrexate tablets 2.5 mg will be replaced with the the first dose of the weekly regimen
Route of administration: Oral
Total duration of therapy
Sponsors
Lotus Pharmaceutical Co Ltd
Norwich Clinical Services Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the rate and extent of Methotrexate absorption after oral administration and to assess the bioequivalenceTimepoint: To assess the bioequivalence, blood sample collection will be performed at pre-dose (0.000 hour) and post-dose blood samples will be collected at 0.250 , 0.500 , 0.667 , 0.833 , 1.000 , 1.250 , 1.500 , 1.750 , 2.000 , 2.500 , 3.000 , 4.000 , 6.000 , 8.000 , 10.000 and 12.000 (12 hours) after dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of both the formulations on the basis of clinical and laboratory examination, documentation of the Adverse Events (AEs) and or Adverse Drug Reactions (ADRs).Timepoint: safety and tolerability will be assessed by performing the health check up in regular intervals (at the time of check-in within 02 hours prior to dosing, 02, 04 and 08 hours post-dose),lab investigations and by documenting the Adverse Events | — |
Countries
India
Contacts
Public ContactDr Rajeev Siddaraj
Norwich Clinical Services Pvt. Ltd.
Outcome results
None listed