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Clinical trial

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.

NCT02940561 is registered in ClinicalTrials.gov with Amneal Pharmaceuticals, LLC as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Amneal Pharmaceuticals, LLC
Phase
Phase 1
Overall status
Unknown status
Start date
August 31, 2016
Completion date
October 31, 2016
Enrollment
48 (estimated)
Sites
3

Conditions

As the registry lists them; a condition with its own page is linked.

psoriasis, rheumatoid arthritis