Value through Innovation27 July 2016

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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