Value through Innovation27 July 2016

Clinical Study Results

  • ALESION ® - Healthy
    Clinical Study Number 262.252
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    A trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, compared to the Reference Product Tablets

    Study Document Trial synopsis 262.252_CO english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.254
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Double-blind, randomised, parallel trial to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, twice a day, versus Epinastine 10 mg alone, twice a day, in the treatment of outpatients with perennial allergic rhinitis

    Study Document Trial synopsis 262.254 english
  • ALESION ® - Healthy
    Clinical Study Number 262.255
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    Study of the pharmacokinetic interactions and relative bioavailability of epinastine and pseudoephedrine in healthy volunteers, comparing tablets containing the fixed combination of the two substances with tablets containing each of the two substances separately

    Study Document Trial synopsis 262.255_CO english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.258
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Phase III Double-blind Comparative Study of WAL 801 CL Dry Syrup in Paediatric Perennial Allergic Rhinitis

    Study Document Trial synopsis 262.258 english
  • ALESION ® - Dermatitis, Atopic
    Clinical Study Number 262.259
    Study Indication Dermatitis, Atopic
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Phase III Double-Blind Comparative Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

    Study Document Trial synopsis 262.259 english
  • ALESION ® - Dermatitis, Atopic
    Clinical Study Number 262.260
    Study Indication Dermatitis, Atopic
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

    Study Document Trial synopsis 262.260 english
  • ALESION ® - Healthy
    Clinical Study Number 262.261
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled single increasing dose tolerance study in healthy male volunteers after intranasal application of Epinastine Nasal (dosage: 0.035 mg (0.025% solution)- 0.42 mg (0.3 % solution))

    Study Document Trial synopsis 262.261 english
  • ALESION ® - Healthy
    Clinical Study Number 262.284
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 20 mg of the new formulation of WAL 801 CL dry syrup compared to 20 mg of the conventional formulation of WAL 801CL dry syrup following oral administration in healthy male volunteers (an open-label, randomised, single-dose, 2x2 crossover study)

    Study Document Trial synopsis 262.284_CO english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.290
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Tablet

    Study Document Trial synopsis 262.290 english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.293
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Dry Syrup - Drug Use - Results Survey of Alesion® Dry Syrup-

    Study Document Trial synopsis 262.293 english
  • ALESION ® - Urticaria
    Clinical Study Number 262.294
    Study Indication Urticaria
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Dry Syrup - Special Drug Use - Results Survey of Aleson® Dry Syrup-

    Study Document Trial synopsis 262.294 english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.