A study to assess interactions between furosemide and ipragliflozin
Research type
Research Study
Full title
A clinical pharmacological study to assess pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin in healthy subjects.
IRAS ID
81698
Contact name
Ashley Brooks
Sponsor organisation
Astellas Pharma Europe B.V. (APEB)
Eudract number
2010-024071-98
Research summary
ASP1941 is being developed as an oral-tablet formulation for mono-therapy and/orCombination therapy for treatment of type 2 diabetes mellitus (T2DM).This will be a study to assess interactions between furosemide and the study drug in healthy subjects.This will be a three-period, multiple dose study. Subjects will receive the three following dose regimens in randomized order:A. Study Drug ASP1941: 150 mg once daily for 5 daysB. Furosemide: 40 mg once daily for 5 days C. Study drug ASP1941 furosemide: 150 mg Study Drug ASP1941 once daily for 5 days 40 mg furosemide once daily for 7 daysIn total 24 healthy male and female subjects will be randomized. Subjects will be admitted to the clinical unit for 3 periods of 13 days (12 nights) each. Admission is on Day -5. Starting from admission to day 5 (10 days) subjects will be given meals and drinks in which electrolytes are controlled to certain pre determined levels. There is a 5 or 7 day dosing period from Day 1 onwards. There will be a wash-out period of at least 7 days between periods. Subjects will have another visit to the unit around 7 to 14 days after the completion of the third treatment period.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
11/IE/0102
Date of REC Opinion
27 Jun 2011
REC opinion
Favourable Opinion