Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01418365
- Lead Sponsor
- Shire
- Brief Summary
Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole 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 Metronidazole + MMX placebo Metronidazole + MMX Mesalazine/mesalamine placebo - Metronidazole + MMX Mesalazine/mesalamine Metronidazole + MMX Mesalazine/mesalamine -
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole 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) at Steady State for Metronidazole 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRA International
🇺🇸Lenexa, Kansas, United States