Value through Innovation27 July 2016

Clinical Study Results

  • Cilobradine - Healthy
    Clinical Study Number 503.204
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamic effects, safety and tolerability of 2 mg and 5 mg cilobradine, administered p.o. once daily over 14 days to healthy male and female volunteers in a randomised, placebo-controlled, double blind study, with an open-label uncontrolled intra-individual comparison to 400 mg moxifloxacin single dose in a subset of volunteers.

    Study Document Trial synopsis 503.204_CO english
  • Cilobradine - Healthy
    Clinical Study Number 503.209
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and pharmacokinetics of [14C]-DK-AH 269 CL after administration of single doses of 5 mg [14C]-DK-AH 269 CL intravenously and 10 mg [14C]-DK-AH 269 CL as oral solution in a parallel-group design in 12 healthy male volunteers.

    Study Document Trial synopsis 503.209_CO english
  • Cilobradine - Healthy
    Clinical Study Number 503.213
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    The effect of cytochrome P 450 3A4 inhibition by itraconazole on the single oral dose pharmacokinetics of cilobradine (an open-label, randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 503.213_CO english
  • Cilobradine - Healthy
    Clinical Study Number 503.203
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamic effects, safety and tolerability of 0.25 mg, 0.5 mg,1 mg and 2 mg cilobradine, compared to 190 mg metoprolol succinate and placebo, administered p.o. once daily over 14 days to healthy volunteers in a randomised, placebo-controlled, partly double blind study, with a 4 mg/14 mg and 10 mg/20 mg cilobradine single dose versus placebo substudy (double blind, three-fold crossover).

    Study Document Trial synopsis 503.203 english

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