A clinical trial intended to compare two formulations of Methotrexate tablets 2.5 mg, in patients with mild to severe psoriasis or Rheumatoid Arthritis.

Not Applicable

Completed

Conditions: Health Condition 1: null- Mild to Severe Psoriasis or Rheumatoid Arthritis

Registration Number: CTRI/2014/04/004522

Lead Sponsor: Cadila Healthcare limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

1. Males or non pregnant, non lactating females between 18-65 years of age (both inclusive).

2. Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18.

3. Patients with mild to severe Psoriasis or Rheumatoid Arthritis who are receiving methotrexate 2.5 mg orally every 12 hours for 3 doses

4. Able to give written informed consent to participate in the study

5. All patients should be judged eligible by the principal investigator or co-investigator or physician during a pre-study safety assessment performed within 21 days of the first dose of study medication

Exclusion Criteria

1. History of allergic responses to Methotrexate or other related drugs or any of its formulation ingredients.

2. Liver dysfunction or Renal dysfunction

3. Patients suffering from alcoholic liver disease or chronic liver disease or receiving other potential hepatotoxic drugs

4. Patients who have pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia

5. Patients currently suffering from or having a history of malignant lymphoma or tumor lysis syndrome

6. Patients suffering from any acute infection within two weeks prior to randomization.

7. Patients suffering from lung disease or skin reactions due to methotrexate.

8. Participation in any investigational drug study within 30 days prior to randomization.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters Cmax, AUC24, AUCt and TmaxTimepoint: In each period, The pre-dose blood sample on Day 1, will be collected 8.0 ml within 30 minutes before dosing time and 4 ml after dosing at At 0.167, 0.33, 0.50, 0.67,0.83, 1.00, 1.25, 1.50, 1.75, <br/ ><br>2.00, 2.25, 2.50, 3.00, 3.50, <br/ ><br>4.00, 5.00, 6.00, 8.00, 10.00 <br/ ><br>and 12.00 hours.

Secondary Outcome Measures