Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01402947 | Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine | PHASE1 | COMPLETED | 30 | — | — | Jul 25, 2011 | Aug 30, 2011 | Jun 9, 2021 | 1 | United States |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Ciprofloxacin + MMX placebo | EXPERIMENTAL | - |
| MMX Mesalazine/mesalamine + Ciprofloxacin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ciprofloxacin XR + MMX Placebo | 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 XR | 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 |
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, ...