Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

开始日期2011-11-01

申办/合作机构

Duke University

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100 项与磺庚甲泼尼龙相关的临床结果

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100 项与磺庚甲泼尼龙相关的转化医学

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100 项与磺庚甲泼尼龙相关的专利（医药）

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项与磺庚甲泼尼龙相关的文献（医药）

2000-09-01·Current opinion in investigational drugs (London, England : 2000)

Methylprednisolone suleptanate Pharmacia Corp.

Review

作者: Paggiaro, P

Methylprednisolone suleptanate (Promedrol) is a prodrug of methylprednisolone being developed by Pharmacia Corp (formerly Pharmacia & Upjohn) for the treatment of asthma. It has been approved for this indication in Switzerland and is awaiting registration in several other countries [211246]. Preliminary preclinical data indicated the potential use of methylprednisolone suleptanate for the i.v. treatment of immunological disease. Its anti-inflammatory/bronchodilatory effect was demonstrated in mice and rats and in a guinea pig model [271975]. Animal models have also demonstrated the use of methylprednisolone suleptanate for the treatment of nephritis and hypotension. Efficacy and safety of pulse therapy Promedrol was demonstrated in a phase II trial using lupus nephritis patients. The recommended dose for pulse therapy is 400 mg equivalent/day i.v. [271975]. Other studies in lupus patients have shown that doses of up to 1000 mg/day are well tolerated [307789] and pulse therapy with either 400 or 800 mg/day are efficacious in delaying the onset of CNS symptoms in SLE patients with organic brain disease [307512]. Preclinical studies are also taking place for the potential treatment of spinal cord injury [344254]. In April 2000, Morgan Stanley Dean Witter estimated sales would be US $281 million in 2003, rising to $277 million in 2004 [375906].

1998-01-01·Journal of Pharmaceutical Sciences3区 · 医学

Photodegradation Products of Methylprednisolone Suleptanate in Aqueous Solution—Evidence of a Bicyclo[3.1.0]hex-3-en-2-one Intermediate

3区 · 医学

Article

作者: Tsutomu Tahara ; Yukimi Noro ; Mayumi Yamada ; Toshihide Nishimura ; Minoru Ogata

Two major photodegradation products of methylprednisolone suleptanate (sodium 11 beta, 17 alpha-dihydroxy-6 alpha-methyl-21-[[8-[methyl(2-sulfoethyl)amino]-1,8-dioxooctyl+ ++]oxy]-pregna-1,4-diene-3,20-dione) in aqueous solution irradiated with white fluorescent light at 2000 lux for 28 days at 25 degrees C were isolated by preparative high-performance liquid chromatography and characterized. Structures of the photodegradation products were determined as sodium 11 beta,17 alpha-dihydroxy-5 alpha, 6 alpha-dimethyl-21-[[8-[methyl(2-sulfoethyl)amino]-1,8-dioxoocty l]-oxy]-19-norpregna-1(10),3-diene-2,20-dione and sodium 1 beta, 11 beta-epoxy-17 alpha-hydroxy-6 alpha-methyl-21-[[8-[methyl(2-sulfoethyl)amino]-1, 8-dioxooctyl]oxy]-19 alpha-pregn-4-ene-2.20-dione. Formation of these compounds, especially the 1,11-epoxy analogue, strongly supports the existence of the bicyclo[3.1.0]hex-3-en-2-one intermediate in the photorearrangement of steroidal cross-conjugated dienones. The intermediate can account for all the major ketonic and phenolic products; these products are generated from the intermediate after subsequent transformations and/or further skeletal rearrangements. The 1,11-epoxy analogues were obtained from the prednisolone steroids in high yields by irradiation with a high-pressure mercury lamp.

1997-06-01·British Journal of Clinical Pharmacology2区 · 医学

A comparative population pharmacokinetic analysis for methylprednisolone following multiple dosing of two prodrugs in patients with acute asthma

2区 · 医学

Article

作者: S. A. Wood ; P. T. Daley‐Yates ; T. J Parker

Aims To conduct a randomized, parallel group comparison of the population pharmacokinetics of the two methylprednisolone (MP) prodrugs Promedrol (MP suleptanate) and Solu‐Medrol (MP succinate) in patients hospitalized with acute asthma.Methods Ninety volunteers were included in the pharmacokinetic analysis. Each volunteer received a dosage regimen of 40 mg (MP equivalents) i.v. 6 hourly for 48 h. The bio‐conversion and disposition of a 40 mg (MP equivalent) i.v. dose of either MP suleptanate or MP succinate to MP was modelled as a first order input, and a mono‐exponential elimination phase.Results Population modelling indicated that the only difference in MP pharmacokinetics between MP suleptanate and MP succinate was in the input rate constant (66.0 h−1vs 5.5 h−1 respectively). Based on individual Bayesian estimates, the exposure of patients to MP was marginally lower for MP suleptanate although the parameter estimates were not significantly different for half‐life (2.7 h vs 3.0 h), steady‐state AUC (2007.0 ng ml−1 h vs 2321.0 ng ml−1 h) and steady‐state Cmax (698.4 ng ml−1vs 647.8 ng ml−1 ) for MP suleptanate and MP succinate respectively.Conclusions It was concluded that for the multiple dosage regimen used in patients with acute asthma the systemic exposure to MP following dosing with MP suleptanate is similar to that arising from MP succinate. In addition the differences in the pharmacokinetics for the prodrugs resulted in only a small difference in the relative bioavailability of MP for MP suleptanate (0.94) compared with MP succinate.

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