Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine

NCT ID: NCT01402947

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-25
• Study Completion Date: 2011-08-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciprofloxacin + MMX placebo

Group Type: EXPERIMENTAL

Ciprofloxacin XR + MMX Placebo

Intervention Type: DRUG

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

MMX Mesalazine/mesalamine + Ciprofloxacin

Group Type: EXPERIMENTAL

MMX Mesalazine/mesalamine + Ciprofloxacin XR

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Lialda

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

PRA International

Lenexa, Kansas, United States

Countries

United States

References

Pierce D, Corcoran M, Martin P, Barrett K, Inglis S, Preston P, Thompson TN, Willsie SK. Effect of MMX(R) 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.

Reference Type: DERIVED

PMID: 24868146 (View on PubMed)

Other Identifiers

SPD476-115

Identifier Type: -

Identifier Source: org_study_id