Health Condition 1: null- Patients with mild to severe psoriasis or rheumatoid arthritis
Conditions
Interventions
Intervention1: Methotrexate Tablets USP, 2.5 mg (Amneal Pharmaceuticals): On day 1 of each period, each patient would receive their dose of Methotrexate 2.5 using either the test or reference product
Sponsors
Amneal Pharmaceuticals USA
Accutest Research Laboratories I PVt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or Women, between 18 to 65 years of age (both inclusive). 2. Ability to provide informed consent prior to participation in the study 3. Patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours (7.5 mg per week in three divided doses). 4. Confirmed diagnosis of psoriasis by clinical examination or after dermatologic consultation. or Confirmed diagnosis of mild to severe rheumatoid arthritis based on at least 1 of the following: i. Documented history of positive rheumatoid factor ii. Current presence of rheumatoid factor iii. Radiographic erosion within 12 months prior to enrollment iv. Presence of serum anti-cyclic citrullinated peptide antibodies (anti-CCP). 5. Women of childbearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation within past 6 months) must have a negative serum pregnancy test at screening and negative urine pregnancy test on check in to housing, and must agree to use an adequate method of contraception. 6. Patientâ??s screening laboratory assessment (complete blood count [CBC] and blood chemistries) are clinically non-significant as per the discretion of the Investigator. 7. No history of addiction to any recreational drug or drug dependence. 8. No participation in any clinical study within the past 60 days prior to receiving the first dose of investigational product for the current study.
Exclusion criteria
Exclusion criteria: 1.A history of allergic or adverse reactions to Methotrexate Sodium or any related drug or any excipient of methotrexate tablets. 2.Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial and at least for 3 months (for males) and for at least one ovulatory cycle (for females) after last dose of study medication. 3.Patients with alcoholism, alcoholic liver disease or other chronic liver disease. 4.Patients who are diagnosed to be HIV or Hepatitis B or Hepatitis C Virus reactive/positive. 5.Patients who have clinically significant abnormal laboratory values at screening. 6.Patients with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results except study indication. 7.Patients who have overt or laboratory evidence of immunodeficiency syndromes. 8.Patients currently suffering from or having a history of malignant lymphoma or tumor lysis syndrome. 9.Patients who have pre-existing hematopoietic impairment/ blood dyscrasias, such as bone marrow hypoplasia, aplastic anemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia and or significant anemia. 10.Patient with lymphadenopathy and lymphoproliferative disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetic profile of Methotrexate Tablets USP, 2.5 mg of Amneal Pharmaceuticals, compared to that of the Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024 USA in patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their bioequivalence.Timepoint: The pre-dose blood sample (00.00) will be collected within 5 minutes before dosing on Day 1 of each period. On day 1, the post-dose blood samples will be drawn at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 7.000, 8.000, 10.000 and 12.000 following drug administration in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of PatientTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Prayag Shah
Amneal Pharmaceuticals Pvt. Ltd.
Outcome results
None listed