Overview

Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

Status:
Completed
Trial end date:
2011-10-05
Target enrollment:
0
Participant gender:
All
Summary
Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone & in combination with MMX® Mesalazine/mesalamine
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Shire
Treatments:
Mesalamine
Metronidazole
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
metronidazole, closely related compounds, or any of the stated ingredients

7. A history of, or current, pancreatitis.