Value through Innovation27 July 2016

Clinical Study Results

  • Ritobegron - Healthy
    Clinical Study Number 1207.1
    Study Indication Healthy
    Product Ritobegron
    Generic Name Ritobegron
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses (40 to 320 mg) of KUC-7483 tablets in healthy male volunteers (double-blind at each dose level, randomised, placebo controlled study) as well as food effects at 80 mg (intraindividual testing in the same volunteers).

    Study Document Trial synopsis 1207.1 english
  • Ritobegron - Healthy
    Clinical Study Number 1207.2
    Study Indication Healthy
    Product Ritobegron
    Generic Name Ritobegron
    Lab Code
    Clinical Phase I
    Study Title

    Open label, randomized, single-dose, five-way crossover study to investigate the regional drug absorption of 80 mg KUC 7483 CL administered via an Enterion™ capsule compared to an immediate release formulation in healthy male volunteers.

    Study Document Trial synopsis 1207.2_CO english
  • Ritobegron - Healthy
    Clinical Study Number 1207.22
    Study Indication Healthy
    Product Ritobegron
    Generic Name Ritobegron
    Lab Code
    Clinical Phase I
    Study Title

    A double-blinded, randomised, placebo controlled, five-way crossover study with one positive control (open-label) (moxifloxacin) to assess the influence of oral single dose KUC 7483 BS (40mg, 80mg, 160mg, 320mg) on the QT/QTc interval of the ECG in healthy male and female volunteersA single-blinded, randomised, placebo controlled, four-way cross-over study with a positive control (open-label) (moxifloxacin) to assess the influence of oral single dose KUC 7483 BS (80mg, 160mg, 320mg) on the QTC interval of the ECG in healthy male and female volunteers

    Study Document Trial synopsis 1207.22 english
  • Ritobegron - Healthy
    Clinical Study Number 1207.26
    Study Indication Healthy
    Product Ritobegron
    Generic Name Ritobegron
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, open label, four-way crossover phase I trial to investigate the in vivo specificity of a single oral dose of 320 mg KUC 7483 CL co-administered with bisoprolol (10 mg daily), propranolol (160 mg daily), and acipimox (500 mg daily) over 5 days and a single inhalative dose of 100 µg salmeterol in healthy male subjects.

    Study Document Trial synopsis 1207.26 english
  • Ritobegron - Healthy
    Clinical Study Number 1207.3
    Study Indication Healthy
    Product Ritobegron
    Generic Name Ritobegron
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (at each dose level), randomised, placebo controlled study to evaluate safety, tolerability and pharmacokinetics of increasing repeated oral doses of KUC 7483 CL tablets (dosage: 40, 120, 180 mg b.i.d.) over 7 days in healthy male volunteers

    Study Document Trial synopsis 1207.3 english
  • Ritobegron - Spinal Cord Injuries
    Clinical Study Number 1207.4
    Study Indication Spinal Cord Injuries
    Product Ritobegron
    Generic Name Ritobegron
    Lab Code
    Clinical Phase I
    Study Title

    A phase I, randomised, double-blind, placebo-controlled study to determine pharmacodynamic effects and pharmacokinetics of a single oral dose of 320 mg KUC-7483 CL in patients with spinal cord injury and neurogenic detrusor overactivity

    Study Document Trial synopsis 1207.4 english
  • Ritobegron - Healthy
    Clinical Study Number 1207.6
    Study Indication Healthy
    Product Ritobegron
    Generic Name Ritobegron
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses (40 to 320 mg) of KUC-7483 tablets in healthy male volunteers (double-blind at each dose level, randomised, placebo controlled study) as well as food effects at 80 mg (intraindividual testing in the same volunteers).

    Study Document Trial synopsis 1207.6 english

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