Value through Innovation27 July 2016

Clinical Study Results

  • ESR 1150 - Healthy
    Clinical Study Number 1172.1
    Study Indication Healthy
    Product ESR 1150
    Generic Name ESR 1150
    Lab Code
    Clinical Phase I
    Study Title

    Absolute bioavailability, pharmacokinetics and safety of ESR 1150 CL 1mg capsule compared to 0.015 mg solution i.v. as single administration in healthy male subjects (open-labelled, 2-way cross-over study)

    Study Document Trial synopsis 1172.1_CO english
  • ESR 1150 - Healthy
    Clinical Study Number 1172.2
    Study Indication Healthy
    Product ESR 1150
    Generic Name ESR 1150
    Lab Code
    Clinical Phase I
    Study Title

    Administration of ESR 1150 CL in ascending doses of 0.5, 1, 2, 4 and 8 mg in an open, group comparison and placebo-controlled design (placebo randomised double blind in the dose groups) for the assessment of safety, tolerability (maximal tolerated dose, MTD), pharmacokinetics and pharmacodynamics in5 groups of 8 female and 5 male healthy subjects, and 4 mg additionally in fed state, in a cross over design (first part of study). Safety, tolerability and pharmacokinetics of MTD/4, MTD/2 and MTD in 6 healthy male subjects, identified as CYP2D6 and/or "spartein" poor metabolizers, in a 3-fold cross over, open study (second part of study)

    Study Document Trial synopsis 1172.2_CO english

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