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

â??An Open-Label, Randomized, Single-dose, Two-period, Two-treatment, Two-sequence, Crossover, Multicentre, Bioequivalence study of Methotrexate tablets 2.5 mg of Cadila Healthcare ltd., India and Methotrexate tablets 2.5 mg of Dava Pharmaceuticals, USA in adult patients with mild to severe Psoriasis or Rheumatoid Arthritis under fasting conditions.â??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004522
Enrollment
32
Registered
2014-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Methotrexate tablets 2.5 mg, manufacture by Cadila Healthcare Limited.: Each patient will be administered one dose methotrexate in first day of either on period I or Period II. Control

Sponsors

Cadila Healthcare limited
Lead Sponsor
Cliantha Research Limited
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00 and 12.00 hours.—

Secondary

MeasureTime frame
To monitor the adverse events and to ensure the safety of Patient Timepoint: NA—

Countries

India

Contacts

Public ContactDr Chirag Shah

Cliantha Research India Limited

cgautam@clianthatrials.com07966135655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026