Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

Study Overview
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Brief Summary
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Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone & in combination with MMX® Mesalazine/mesalamine

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Metronidazole + MMX Mesalazine/mesalamine placebo
* Drug: Metronidazole + MMX Mesalazine/mesalamine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole + MMX placebo<br> | Drug: Metronidazole + MMX Mesalazine/mesalamine placebo<br>* 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<br>|
| Experimental: Metronidazole + MMX Mesalazine/mesalamine<br> | Drug: Metronidazole + MMX Mesalazine/mesalamine<br>* 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<br>* Other names: Lialda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole | 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. | Assessed over a 24-hour period starting post-dose on day 4 | 
| Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole | 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. | Assessed over a 24-hour period starting post-dose on day 4 |