To characterize the pharmacokinetic profile of the Test product - Methotrexate Tablets USP,
2.5 mg of Amneal Pharmaceuticals, compared to that of the corresponding Reference product -
Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc. 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.