297
Participants
Start Date
July 1, 2018
Primary Completion Date
April 28, 2019
Study Completion Date
April 28, 2019
BLI800
Two bottles of BLI800 are needed for appropriate cleansing of the bowel. Prior to administration, the content of each bottle must be diluted in water, using the cup provided, to a total volume of approximately 0.5 L, and must be followed by the ingestion of 1 additional litre of water.
Fortrans®
Fortrans® (Powder for Oral Solution) will be given according to Chinese approved Summary of Product Characteristics (SmPC). Fortrans® is provided as a powder for Polyethylene Glycol (PEG) based solution available in sachets containing a white powder readily miscible with water. The dosing for Fortrans® administration will be adapted to subjects' body weight as following: 1 L of solution for 15 to 20 kg, an average of 3 to 4 L (maximum 4 L).
Peking University First Hospital, Beijing
Beijing Frendship hospital,Capital Medical University, Beijing
Peking Union Medical College Hospital, Beijing
Zhong Shan Hospital, Shanghai
Jiangsu Province Hospital, Nanjing
Tianjin Medical University General Hospital, Tianjin
The Second Affiliated Hospital Zhe Jiang University of School, Hangzhou
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan
The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou
West China Hospital, Sichuan University, Chengdu
Lead Sponsor
Ipsen
INDUSTRY