Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MMX Mesalazine/mesalamine+ Ciprofloxacin · 1 trial · 1 indication
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, ...
MMX Mesalazine/mesalamine + Ciprofloxacin is a combination of MMX mesalazine, also called mesalamine, with ciprofloxacin XR. It is a small molecule combination developed by Takeda Pharmaceutical Company Limited. The pairing has been studied in a Phase 1 drug interaction trial in healthy adult volunteers.
Takeda Pharmaceutical Company Limited develops MMX Mesalazine/mesalamine + Ciprofloxacin. Takeda trades under the ticker TAK. The company sponsored the Phase 1 drug interaction study of ciprofloxacin XR with MMX mesalazine/mesalamine conducted in the United States.
MMX Mesalazine/mesalamine + Ciprofloxacin is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a randomized, controlled drug interaction study of ciprofloxacin XR with MMX mesalazine/mesalamine in healthy volunteers.
MMX Mesalazine/mesalamine + Ciprofloxacin has been studied in one clinical trial, NCT01402947, titled Ciprofloxacin XR Drug Interaction Study With MMX Mesalazine/Mesalamine. That Phase 1 trial enrolled 30 healthy adult volunteers in the United States, was randomized and controlled, and is now completed.
The completed trial, NCT01402947, evaluated the drug interaction between ciprofloxacin XR and MMX mesalazine/mesalamine. It was a Phase 1, randomized, controlled study in 30 healthy volunteers aged 18 years and older in the United States. The study is listed as completed.