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Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

This study has been completed.
Information provided by (Responsible Party):
Shire Identifier:
First received: August 15, 2011
Last updated: August 21, 2013
Last verified: August 2013
Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone & in combination with MMX® Mesalazine/mesalamine

Condition Intervention Phase
Drug: Metronidazole + MMX Mesalazine/mesalamine placebo
Drug: Metronidazole + MMX Mesalazine/mesalamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Metronidazole Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole [ 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 how much and how long a drug stays in a body.

  • Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole [ 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.

Enrollment: 30
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole + MMX placebo Drug: Metronidazole + MMX Mesalazine/mesalamine placebo
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally
Experimental: Metronidazole + MMX Mesalazine/mesalamine Drug: Metronidazole + MMX Mesalazine/mesalamine
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
Other Name: Lialda


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 metronidazole, closely related compounds, or any of the stated ingredients
  7. A history of, or current, pancreatitis.
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Please refer to this study by its identifier: NCT01418365

United States, Kansas
PRA International
Lenexa, Kansas, United States
Sponsors and Collaborators
Study Director: Patrick Martin Shire
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shire Identifier: NCT01418365     History of Changes
Other Study ID Numbers: SPD476-116
Study First Received: August 15, 2011
Results First Received: July 16, 2012
Last Updated: August 21, 2013

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on April 28, 2017