Status:
COMPLETED
Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Lead Sponsor:
Shire
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone \& in combination with MMX® Mesalazine/mesalamine
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- 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
- 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).
- A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
- 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.
- A history of or current clinically relevant moderate or severe renal or hepatic impairment.
- A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
- Known or suspected intolerance or hypersensitivity to the investigational product or metronidazole, closely related compounds, or any of the stated ingredients
- A history of, or current, pancreatitis.
Exclusion
Key Trial Info
Start Date :
August 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01418365
Start Date
August 22 2011
End Date
October 5 2011
Last Update
June 9 2021
Active Locations (1)
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1
PRA International
Lenexa, Kansas, United States