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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose regimens of Ceftaroline
A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 600 mg Ceftaroline fosamil 1 h infusion |
|
| B | Experimental | Placebo 1 h infusion |
|
| C | Experimental | 600 mg Ceftaroline fosamil 2 h infusion |
|
| D | Experimental | Placebo 2 h infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 600 mg Ceftaroline fosamil | Drug | 1 h infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability in terms of adverse events, laboratory data, vital signs following single and multiple dose regimens of ceftaroline fosamil compared to placebo | Screening up to 19 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma concentration-time curve from zero to infinity (AUC), area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)]; area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion [AUC(0-12), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Melnick, MD | AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437 | Study Director |
| Elizabeth Tranter, MBCHB MRCP | Hammersmith Medicines Cumberland Avenue London NW10 7EW UK | Principal Investigator |
| Mirjana Kujacic, MD | AstraZeneca Research and DevelopmentSE-431 83 MolndalSweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30380060 | Derived | Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439. | |
| 26152131 | Derived | Yang L, Sunzel M, Xu P, Edeki T, Wilson D, Li J, Li H. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects. Int J Clin Pharmacol Ther. 2015 Aug;53(8):681-91. doi: 10.5414/CP202343. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Drug |
1 h infusion |
|
| 600 mg Ceftaroline fosamil | Drug | 2 h infusion |
|
| Placebo | Drug | 2 h infusion |
|
| Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), area under the plasma concentration time curve from zero to time of the last quantifiable concentrations [AUC(0-t)], area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %) | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma concentration-time curve from zero to infinity (AUC), area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)]; area under the plasma concentration-time curve from zero to 8 hours after the start of the infusion [AUC(0-8), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).](streamdown:incomplete-link) | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24 hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), area under the plasma concentration time curve from zero to time of the last quantifiable concentrations [AUC(0-t)], area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %) | Day 1,4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR). | Day 1 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h). | Day 8 |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma concentration-time curve from zero to infinity (AUC), area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)]; area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion [AUC(0-12), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).](streamdown:incomplete-link) | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), area under the plasma concentration time curve from zero to time of the last quantifiable concentrations [AUC(0-t)], area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %) | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma concentration-time curve from zero to infinity (AUC), area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)]; area under the plasma concentration-time curve from zero to 8 hours after the start of the infusion [AUC(0-8), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).](streamdown:incomplete-link) | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), area under the plasma concentration time curve from zero to time of the last quantifiable concentrations [AUC(0-t)], area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %) | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma concentration-time curve from zero to infinity (AUC), area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)]; area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion [AUC(0-12), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).](streamdown:incomplete-link) | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), area under the plasma concentration time curve from zero to time of the last quantifiable concentrations [AUC(0-t)], area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI,%) | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma concentration-time curve from zero to infinity (AUC), area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)]; area under the plasma concentration-time curve from zero to 8 hours after the start of the infusion [AUC(0-8), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).](streamdown:incomplete-link) | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), area under the plasma concentration time curve from zero to time of the last quantifiable concentrations [AUC(0-t)], area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %) | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CL R). | Day 1 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h). | Day 8 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR). | Day 1 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h). | Day 8 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR). | Day 1 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h). | Day 8 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR). | Day 1 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h). | Day 8 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR). | Day 1 |
| Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h). | Day 8 |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24 hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor. Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1,4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor. Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline). | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion | Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor. | Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| 24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion | Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor. | Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose |
| CSR-D3720C00010.pdf | View source |
| Clinical\_Study\_Protocol-Redacted-13.03.14 | View source |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |