107
Participants
Start Date
August 16, 2017
Primary Completion Date
October 15, 2019
Study Completion Date
October 15, 2019
SENS-111 100mg
SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
SENS-111 200mg
SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
Placebo Oral Tablet
Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
Bajcsy-Zsilinszky Kórház és Rendelőintézet, Budapest
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ, Szeged
Pécsi Tudományegyetem, ÁOK Klinikai Központ, Pécs
Columbia University Medical Center, New York
Klinikum Unfallkrankenhaus Berlin, Berlin
Seoul National University Bundang Hospital, Gyeonggi-do
Ospedale San Raffaele IRCCS, Milan
Universitätsklinikum Schleswig-Holstein Ratzeburger, Lübeck
CHU Gui de Chauliac, Montpellier
Chungnam National University Hospital, Junggu
Hillel Yaffe Medical Center, Hadera
University Hospital Hradec Králové, Hradec Králové
Chonnam National University Hospital, Donggu
Hôpital Lariboisière, Paris
Klinikum der Universität München, Munich
Soroka Medical Center, Beersheba
Kreiskliniken Altötting, Altötting
Rambam Health Care Campus, Haifa
Carmel Medical Center, Haifa
Meir Medical Center, Kfar Saba
Rabin Medical Center, Petah Tikva
St. Paul's Hospital, The Catholic University of Korea, Seoul
Asan Medical Center, Seoul
Gangnam Severance Hospital, Seoul
Lead Sponsor
Sensorion
INDUSTRY