Phase 1Status unknown
BE Study in Patients - Methotrexate Tablets
A Multicenter, Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single-dose, Two-way, Crossover, Bioequivalence Study of Methotrexate Tablets USP, 2.5 mg Manufactured by Amneal Pharmaceuticals, With 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 Under Fasting Condition.
- Sponsor
- Amneal Pharmaceuticals, LLC (Industry)
- Enrolment
- 48 planned
- Conditions
- Psoriasis; Rheumatoid Arthritis
- Interventions
- Methotrexate - Amneal; Methotrexate - DAVA
- Ages
- adults, older adults
- Registry
- NCT02940561
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Area Under the Curve (AUC0-12)
- Maximum Plasma Concentration (Cmax)
History
Registered
Primary completion
Started