Value through Innovation27 July 2016

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Clinical Study Results

  • Sarakalim - Healthy
    Clinical Study Number 1150.1
    Study Indication Healthy
    Product Sarakalim
    Generic Name Sarakalim
    Lab Code
    Clinical Phase I
    Study Title

    A single increasing dose safety, tolerability and pharmacodynamics (methacholine challenge) study after inhalational administration of BIIX 1 XX (single doses:5 - 800 mcg) in healthy young male volunteers (randomised, double­blind, placebo- controlled).

    Study Document
    Trial synopsis 1150.1 english
  • Sarakalim - Healthy
    Clinical Study Number 1150.3
    Study Indication Healthy
    Product Sarakalim
    Generic Name Sarakalim
    Lab Code
    Clinical Phase I
    Study Title

    A multiple increasing dose safety and tolerability study after inhalational administration of BIIX 1 XX (100 mcg, 200 mcg, 400 mcg b.i.d. for 14 days) in healthy male volunteers (randomised, double-blind within each dose group, placebo-controlled, parallel-group).

    Study Document
    Trial synopsis 1150.3_CO english
  • Sarakalim - Healthy
    Clinical Study Number 1150.7
    Study Indication Healthy
    Product Sarakalim
    Generic Name Sarakalim
    Lab Code
    Clinical Phase I
    Study Title

    A single increasing dose safety and tolerability study (dose extension) after inhalational administration of BIIX 1 XX (single doses: 800-2000 mcg) in healthy young male volunteers (randomised, double-blind, placebo-controlled)

    Study Document
    Trial synopsis 1150.7 english