A clinical trial to study the effects of two drugs, Methotrexate / Imeth® in Patients with Rheumatoid Arthritis under fasting condition

INTERVENTION: Intervention1: Test‐ Methotrexate (as Methotrexate Sodium) 3 x 5 mg modified‐immediate release capsules.: NIL Control Intervention1: Reference ‐ Imeth® 6 x 2.5 mg (methotrexate 15 mg) immediate release tablets: NIL CONDITION: rheumatoid arthritis PRIMARY OUTCOME: Bioavailability of the both the formulations (T vs R) will be assessed in relation to the ; primary pharmacokinetic parameters for methotrexate: ; ï??ï? Cmax ; ï??ï? AUC(0‐t) ; ‐‐‐‐‐‐Timepoint: D15 SECONDARY OUTCOME: To monitor safety parameters for all the investigational products by performing the clinical ; and laboratory examinations and recording adverse events during the study. ; To determine and compare secondary pharmacokinetic parameters of test and reference ; products for methotrexate, i.e. ; AUC0â??â?? ; ï??ï? tmax ; ï??ï? Kel ; ï??ï? t1/2 ; ï??ï? AUCres ; ï??ï? Intra & inter‐subject variability ; ‐‐‐‐‐‐Timepoint: D15 INCLUSION CRITERIA: Inclusion Criteria 1. Adult patients suffering from rheumatoid arthritis; aged between 18 to 50 years (both inclusive) 2. Patients should already be receiving oral methotrexate 15 mg once weekly for rheumatoid arthritis. 3. Patients willing to voluntarily provide written informed consent. 4. Patients willing to undergo pre and post‐study physical examinations and laboratory investigations. 5. Patients willing to adhere to protocol and they should not consume coffee, tea, chocolate, grape fruit juice or soft drink at least 24 hours prior to investigational product administration (i.e. in‐house monitoring and the remaining based on history) and during their clinical stay in each study period. 6. Patient should be willing to adhere to the protocol and they should not consume alcohol at least 48 hours prior to dosing (i.e. in‐house monitoring and the remaining based on history) and should agree not to take any