Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 44
Healthy volunteers: yes

Brief summary:
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone \& in combination with Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: sulfamethoxazole + MMX placebo intervention 2: Sulfamethoxazole + MMX Mesalazine/mesalamine
Intervention descriptions: intervention 1: 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. intervention 2: 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

Protocol document: