Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01469637
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : October 25, 2012
Last Update Posted : October 25, 2012
Information provided by (Responsible Party):

Brief Summary:
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone & in combination with MMX Mesalazine/mesalamine.

Condition or disease Intervention/treatment Phase
Healthy Drug: sulfamethoxazole + MMX placebo Drug: Sulfamethoxazole + MMX Mesalazine/mesalamine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Sulfamethoxazole Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects
Study Start Date : November 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Sulfamethoxazole + MMX placebo Drug: 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.

Experimental: Sulfamethoxazole + MMX Mesalazine/mesalamine Drug: 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
Other Name: Lialda

Primary Outcome Measures :
  1. Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ]
    AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.

  2. Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ]
    Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01469637

United States, Kansas
PRA Inrernational
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Study Director: Patrick Martin Shire

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shire Identifier: NCT01469637     History of Changes
Other Study ID Numbers: SPD476-117
First Posted: November 10, 2011    Key Record Dates
Results First Posted: October 25, 2012
Last Update Posted: October 25, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents