Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine - Full Text View

Purpose

This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone & in combination with MMX Mesalazine/mesalamine.

Condition	Intervention	Phase
Healthy	Drug: Ciprofloxacin XR + MMX Placebo Drug: MMX Mesalazine/mesalamine + Ciprofloxacin XR	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study 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 Ciprofloxacin XR Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Mesalamine Mesalamine hydrochloride Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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:	July 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402947

Locations


United States, Kansas
PRA International
Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

Shire

Investigators


Study Director:	Patrick Martin	Shire

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pierce D, Corcoran M, Martin P, Barrett K, Inglis S, Preston P, Thompson TN, Willsie SK. Effect of MMX® mesalamine coadministration on the pharmacokinetics of amoxicillin, ciprofloxacin XR, metronidazole, and sulfamethoxazole: results from four randomized clinical trials. Drug Des Devel Ther. 2014 May 14;8:529-43. doi: 10.2147/DDDT.S55373. eCollection 2014.


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01402947 History of Changes
Other Study ID Numbers:	SPD476-115
Study First Received:	July 21, 2011
Results First Received:	June 1, 2012
Last Updated:	June 1, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Ciprofloxacin Mesalamine Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors	Cytochrome P-450 Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016