Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Condition: Healthy
Intervention: sulfamethoxazole + MMX placebo; Sulfamethoxazole + MMX Mesalazine/mesalamine
Intervention description: 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.; 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
Intervention MeSH terms: Sulfamethoxazole; Mesalamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-55 years inclusive at the time of consent. The date of signing informed consent
             is defined as the beginning of the Screening Period.

          2. Subject is willing to comply with any applicable contraceptive requirements of the
             protocol and is:

               -  Male, or

               -  Non-pregnant, non-lactating female

               -  Females must be at least 90 days post-partum or nulliparous.

        Exclusion Criteria

          1. A history of current or recurrent disease that could affect the colon. This includes
             gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac
             disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel
             Syndrome. Subjects who have a history of chronic constipation, which is physician
             diagnosed and treated, will also be excluded from the study (frequency of bowel
             movements >48 hours between samples).

          2. A history of current or relevant serious, severe, or unstable (acute or progressive)
             physical or psychiatric illness.

          3. A history of gastrointestinal surgery performed within the past 12 months prior to the
             first dose of investigational product, with the exception of an appendectomy.

          4. A history of or current clinically relevant moderate or severe renal or hepatic
             impairment.

          5. A history of asthma or bronchospasm associated with the use of 5-ASA or other
             non-steroidal anti-inflammatory drugs.

          6. Known or suspected intolerance or hypersensitivity to the investigational product or
             sulfamethoxazole/trimethoprim, closely related compounds, or any of the stated
             ingredients

          7. A history of, or current, pancreatitis