Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01402947
- Lead Sponsor
- Shire
- Brief Summary
This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone \& in combination with MMX Mesalazine/mesalamine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MMX Mesalazine/mesalamine + Ciprofloxacin MMX Mesalazine/mesalamine + Ciprofloxacin XR - Ciprofloxacin + MMX placebo Ciprofloxacin XR + MMX Placebo -
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR 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.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRA International
🇺🇸Lenexa, Kansas, United States