| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State | 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. | The Pharmacokinetic Set (PKS) consisted of all subjects in the Safety Analysis Set who generated sufficient plasma samples to allow reliable determination of Cmax and AUC. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | | Mean | Standard Deviation | ug*h/L | | 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00021411± 11081
- OG00146173± 22864
- OG00249213± 17664
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| Secondary | Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State | The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + [0.7847* Xu0-24h Ac-5-ASA])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours. | | Posted | | Mean | Standard Deviation | percentage of dose absorbed | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Primary | Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State | 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. | | Posted | | Mean | Standard Deviation | ug/L | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | | Posted | | Median | Full Range | hours | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Primary | Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State | Clearance of a substance from the blood by the kidneys. | | Posted | | Mean | Standard Deviation | L/h | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Primary | AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State | | | Posted | | Mean | Standard Deviation | ug*h/L | | 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine Metabolite (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine Metabolite (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine Metabolite (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Primary | Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State | | | Posted | | Mean | Standard Deviation | ug/L | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine Metabolite (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine Metabolite (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine Metabolite (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Primary | Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State | | | Posted | | Median | Full Range | hours | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine Metabolite (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine Metabolite (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine Metabolite (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Primary | CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State | | | Posted | | Mean | Standard Deviation | L/h | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine Metabolite (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine Metabolite (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine Metabolite (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Secondary | Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State | | | Posted | | Mean | Standard Deviation | mg | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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| Secondary | Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State | | | Posted | | Mean | Standard Deviation | mg | | Over a 24-hour period starting on day 7 | | | | ID | Title | Description |
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| OG000 | MMX Mesalamine Metabolite (30mg/kg) | MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG001 | MMX Mesalamine Metabolite (60 mg/kg) | MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | | OG002 | MMX Mesalamine Metabolite (100 mg/kg) | MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
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