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This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone & in combination with MMX Mesalazine/mesalamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin + MMX placebo | Experimental |
| |
| MMX Mesalazine/mesalamine + Ciprofloxacin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR | 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. | Assessed over a 24-hour period starting post-dose on day 4 |
| Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR | 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. | Assessed over a 24-hour period starting post-dose on day 4 |
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Inclusion Criteria
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.
Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24868146 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MMX Placebo + Ciprofloxacin First | MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention |
| FG001 | MMX Mesalazine/Mesalamine + Ciprofloxacin First | MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| ||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MMX Placebo + Ciprofloxacin First | MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR | 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. | Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment. | Posted | Mean | Standard Deviation | ng*h/ml | Assessed over a 24-hour period starting post-dose on day 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MMX Placebo + Ciprofloxacin | MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| 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 |
|
|
| NOT COMPLETED |
|
| BG001 | MMX Mesalazine/Mesalamine + Ciprofloxacin First | MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | MMX Mesalazine/Mesalamine + Ciprofloxacin | MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR | 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. | Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment. | Posted | Mean | Standard Deviation | ng/ml | Assessed over a 24-hour period starting post-dose on day 4 |
|
|
|
|
| 0 |
| 29 |
| 2 |
| 29 |
| EG001 | MMX Mesalazine/Mesalamine + Ciprofloxacin | MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 | 0 | 30 | 8 | 30 |
| Gastroesophogeal reflex disease | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Cellulitis | Infections and infestations |
|
| Flank pain | Musculoskeletal and connective tissue disorders |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Presyncope | Nervous system disorders |
|
| Phlebitis | Vascular disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |