44
Participants
Start Date
November 7, 2011
Primary Completion Date
December 20, 2011
Study Completion Date
December 20, 2011
sulfamethoxazole + MMX placebo
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4.
Sulfamethoxazole + MMX Mesalazine/mesalamine
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4
PRA Inrernational, Lenexa
Lead Sponsor
Shire
INDUSTRY