Value through Innovation27 July 2016

Clinical Study Results

  • LENDORMIN ® - Sleep Initiation and Maintenance Disorders
    Clinical Study Number 263.510
    Study Indication Sleep Initiation and Maintenance Disorders
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blinded, double-dummy, multi-center, paralleled study to investigate the safety and efficacy of Brotizolam (Lendormin) compared with Estazolam in insomnia outpatients.

    Study Document Trial synopsis 263.510_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.511
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    A randomized, single-dose, two-way cross-over study to assess the bioequivalence of Lendormin® Tablets 0.25 mg (Delpharm Reims) vs. Lendormin® Tablets 0.25 mg (Synmosa Biopharma Co. Ltd.) administered to healthy adult volunteers 

    Study Document Trial synopsis 263.511_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.506
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    Clinical Pharmacological study on absorption from mucous membrane of oral cavity of WE 941 OD tablets

    Study Document Trial synopsis 263.506_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.507
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    The bioequivalence between WE 941 OD tablets (0.25 mg as the basis) taken without water and brotizolam conventional tablets (Lendormin® tablets, 0.2Smg as the basis taken with water, as a single administration in healthy adult male subjects (open-labelled, 2-way cross-over study)

    Study Document Trial synopsis 263.507_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.508
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    The bioequivalence between WE 941 OD tablets (0.25mg as the basis) and brotizolam conventional tablets (Lendormin® tablets, 0.25 mg as the basis), both taken with water as a single administration in healthy adult male subjects (open-labelled, 2-way cross-over study)

    Study Document Trial synopsis 263.508_CO english
  • LENDORMIN ® - Sleep Initiation and Maintenance Disorders
    Clinical Study Number 263.509
    Study Indication Sleep Initiation and Maintenance Disorders
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase IV
    Study Title

    Lendormin D® Tablet (Drug Use Result Survey)

    Study Document Trial synopsis 263.509 english

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

European Trial Register of EU studies.