Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
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ClinicalTrials.gov Identifier: NCT01402947 |
Recruitment Status :
Completed
First Posted : July 26, 2011
Results First Posted : July 6, 2012
Last Update Posted : July 6, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Ciprofloxacin XR + MMX Placebo Drug: MMX Mesalazine/mesalamine + Ciprofloxacin XR | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 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 Ciprofloxacin XR Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Ciprofloxacin + MMX placebo |
Drug: Ciprofloxacin XR + MMX Placebo
MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 |
Experimental: MMX Mesalazine/mesalamine + Ciprofloxacin |
Drug: MMX Mesalazine/mesalamine + Ciprofloxacin XR
MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
Other Name: Lialda |
- Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR [ 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) of Ciprofloxacin XR [ 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.

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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
- 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.
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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 ciprofloxacin XR, closely related compounds, or any of the stated ingredients

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 ClinicalTrials.gov identifier (NCT number): NCT01402947
United States, Kansas | |
PRA International | |
Lenexa, Kansas, United States, 66219 |
Study Director: | Patrick Martin | Shire |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01402947 |
Other Study ID Numbers: |
SPD476-115 |
First Posted: | July 26, 2011 Key Record Dates |
Results First Posted: | July 6, 2012 |
Last Update Posted: | July 6, 2012 |
Last Verified: | June 2012 |
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