Value through Innovation27 July 2016

Clinical Study Results

  • BI 113608 - Healthy
    Clinical Study Number 1314.1
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 113608 in healthy male volunteers (randomised, double-blind, placebo-controlled within dose groups)

    Study Document Trial synopsis 1314.1_DS english
  • BI 113608 - Healthy
    Clinical Study Number 1314.2
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 powder for oral solution in healthy male volunteers q.d. or b.i.d. for 14 days (a randomised, double-blind, placebo-controlled within dose groups Phase I trial)

    Study Document Trial synopsis 1314.2 english
  • BI 113608 - Healthy
    Clinical Study Number 1314.3
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    An open label, randomised, single dose, 3-way cross over study to investigate relative bioavailability and food effect on different formulations of BI 113608 in healthy male subjects, followed by fixed sequence periods investigating influence of pantoprazole coadministration and food effect on pharmacokinetics of different formulations of BI 113608

    Study Document Trial synopsis 1314.3 english
  • BI 113608 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1314.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Randomized, placebo-controlled, double-blind within dose groups, multiple rising-dose study to evaluate safety, tolerability, and PK of oral BI 113608 administered as tablets twice daily over 4 weeks in patients with COPD associated with chronic bronchitis

    Study Document Trial synopsis 1314.5 english
  • BI 113608 - Healthy
    Clinical Study Number 1314.7
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Relative bioavailability of single oral dose of BI 113608 when administered alone or in combination with multiple oral doses of ketoconazole or voriconazole in healthy male subjects (an open-label, randomised, three-period cross-over trial)

    Study Document Trial synopsis 1314.7 english
  • BI 113608 - Healthy
    Clinical Study Number 1314.9
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses and multiple rising oral doses of BI 113608 in healthy male Asian and Caucasian volunteers (randomised, double-blind, placebo-controlled within dose groups)

    Study Document Trial synopsis 1314.9 english

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