Value through Innovation27 July 2016

Clinical Study Results

  • BISOLTUSSIN ® - Healthy
    Clinical Study Number 1134.2
    Study Indication Healthy
    Product BISOLTUSSIN ®
    Generic Name Dextromethorphan
    Lab Code
    Clinical Phase I
    Study Title

    A phase I, single dose, controlled two-way crossover trial to evaluate the relative bioavailability of orally administered dextromethorphan syrup (21 mg dextromethorphan hydrobromide monohydrate) in comparison to dextromethorphan soft pastilles (21 mg dextromethorphan hydrobromidemonohydrate) in healthy male and female subjects who are extensive metabolisers for cytochrome P450 (CYP) 2D6

    Study Document Trial synopsis 1134.2_CO english
  • BISOLTUSSIN ® - Healthy
    Clinical Study Number 1134.3
    Study Indication Healthy
    Product BISOLTUSSIN ®
    Generic Name Dextromethorphan
    Lab Code
    Clinical Phase I
    Study Title

    A phase I multiple dose trial to investigate safety with special emphasis on ECG effects and tolerability after oral doses of 30 mg qid and 90 mg qid dextromethorphan hydrobromide monohydrate (2 mg/mL syrup) in healthy male and female subjects for 2 days followed by a morning dose (extensive metabolisers of CYP 2D6) and for 10 days followed by a morning dose (poor metabolisers of CYP 2D6) (randomised, double-blind, placebo-controlled groups)

    Study Document Trial synopsis 1134.3_CO english

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