Value through Innovation27 July 2016

Clinical Study Results

  • MUCOANGIN ® - Pharyngitis
    Clinical Study Number 18.489
    Study Indication Pharyngitis
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase III
    Study Title

    Efficacy and tolerability of Ambroxol Lozenges (Mucoangin®) 20 mg in relieving pain of sore throat in patients with acute viral pharyngitis - A randomised, double-blind, placebo- and active-controlled parallel group study.

    Study Document Trial synopsis 18.489_CO english
  • MUCOANGIN ® - Pharyngitis
    Clinical Study Number 18.490
    Study Indication Pharyngitis
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Double-blind, randomized, placebo-controlled trial to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis

    Study Document Trial Synopsis 18.490_CO english
  • MUCOANGIN ® - Pharyngitis
    Clinical Study Number 18.487
    Study Indication Pharyngitis
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase III
    Study Title

    Efficacy and tolerability of Ambroxol Lozenges 20mg in relieving the pain of sore throat in adolescent patients with acute viral pharyngitis - A randomised, double-blind, placebo-controlled parallel group study. AMBROSIA: Ambroxol Lozenges In Sore throat In Adolescents

    Study Document Trial synopsis 18.487_CO english
  • MUCOANGIN ® - Pharyngitis
    Clinical Study Number 18.504
    Study Indication Pharyngitis
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase II
    Study Title

    A multi-centre, randomised, double-blind, placebo controlled, parallel group dose finding study to assess the efficacy and safety of ambroxol spray (2.5mg, 5mg or 10mg) versus placebo for the temporary relief of sore throat pain in patients with acute pharyngitis

    Study Document Trial synopsis 18.504_CO english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.479
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, two-way crossover study in healthy female and male volunteers to evaluate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge in comparison to 30 mg ambroxol hydrochloride syrup (Mucosolvan®).

    Study Document Trial synopsis 18.479 english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.488
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of ambroxol hydrochloride following oral administration of soft pastilles 15 mg (Test) compared to 15 mg of syrup (15mg/5mL) (Reference I) and compared to 15 mg of syrup (30mg/5mL) (Reference II) in healthy male and female volunteers. An open-label, randomised, single-dose, 3-way crossover study

    Study Document Trial synopsis 18.488 english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.493
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (at each dose level), randomised, placebo controlled phase I study to evaluate safety, tolerability and pharmacokinetics of increasing repeated oral doses of ambroxol lozenges (dosage: 20, 40, 80 mg three times daily) ove r4 days in healthy male volunteers

    Study Document Trial synopsis 18.493_CO english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.494
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the metabolism and pharmacokinetics of an open label single dose of 20 mg ambroxol administered as a lozenge together with an oral solution of 0.4 mg [14C]-ambroxol in healthy male volunteers

    Study Document Trial synopsis 18.494_CO english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.510
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomized, multiple-dose, three-period crossover study in healthy male and female volunteers to characterize pharmacokinetics and assessthe relative bioavailability of two new oral formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg.

    Study Document Trial synopsis 18.510 english

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