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A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions

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A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Nov 2021

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At a glance

  • Drugs Citraconic acid (Primary) ; Dimethyl fumarate
  • Indications Multiple sclerosis
  • Focus Pharmacokinetics
  • Sponsors Banner Life Sciences

    • Most Recent Events

    • 30 Mar 2021 Primary endpoint (The BE comparison of Cmax of MMF between treatments) , has been met according to Results published in the CNS Drugs
    • 30 Mar 2021 Primary endpoint (The bioequivalent (BE) comparison of AUC0-inf of MMF between treatments) , has been met according to Results published in the CNS Drugs
    • 30 Mar 2021 Results published in the CNS Drugs

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