Abstract:
PURPOSE:This Phase 1 pharmacokinetic (PK) comparability study in healthy subjects was performed to compare the PK properties and tolerability of single-dose golimumab 100 mg delivered subcutaneously by an autoinjector device or by a standard needle and syringe that had been used for the subcutaneous (SC) delivery of golimumab in pivotal Phase 3 studies. METHODS:Healthy male subjects were randomly assigned to receive a single injection of SC golimumab 100 mg using either the autoinjector or a standard needle and syringe. The PK parameters of golimumab were calculated using noncompartmental analysis. An ANOVA model was applied to compare the 2 injection methods with regard to golimumab C(max) and the AUC from 0 and 49 days after administration (AUC(0-49d)). FINDINGS:In the prespecified evaluable PK population (n = 141), the mean (SD) values for C(max) were 6.6 (3.3) and 6.0 (3.0) µg/mL, and AUC(0-49d) values were 97.4 (43.2) and 88.9 (36.8) µg·d/mL in the autoinjector and needle/syringe groups, respectively. The 90% CI of the geometric mean ratios of the AUC(0-49d) values between the 2 delivery methods was 95.17% to 120.55%; the 90% CI of the geometric mean ratio of C(max) was 96.14% to 127.42%. In a post hoc intent-to-treat analysis using data from all 156 subjects, the 90% CIs of both C(max) and AUC(0-49d) fell within the prespecified range for bioequivalence (80% to 125%). The prevalences of adverse events were similar between the 2 groups. IMPLICATIONS:The totality of the study findings suggests that the PK properties and tolerability of SC administration of golimumab by the 2 delivery methods were comparable. The study results successfully bridged the container-closure change from a liquid-in-vial product to either a prefilled syringe or an autoinjector with the same liquid formulation.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Xu Z,Marciniak SJ Jr,Frederick B,Kim L,Zhuang Y,Davis HM,Zhou Hdoi
10.1016/j.clinthera.2014.09.012subject
Has Abstractpub_date
2015-02-01 00:00:00pages
427-38issue
2eissn
0149-2918issn
1879-114Xpii
S0149-2918(14)00604-3journal_volume
37pub_type
杂志文章,随机对照试验abstract:PURPOSE:Current data suggest potential benefits with β-lactam plus macrolide combination therapy for empiric treatment of intensive care unit (ICU) patients with severe community-acquired pneumonia (CAP). However, it is unclear whether deescalation to β-lactam monotherapy in the absence of positive results on diagnosti...
journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
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abstract::The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) may be the most significant piece of legislation affecting the practice of pharmacy since the Durham-Humphrey amendments to the Food, Drug and Cosmetic Act. As part of the OBRA-90 legislation, the Health Care Financing Administration (HCFA) was required to publis...
journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:
更新日期:1988-01-01 00:00:00
abstract::Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2005.09.012
更新日期:2005-09-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1989-03-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2012.06.008
更新日期:2012-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1990-01-01 00:00:00
abstract::In its clinical assessment of the respiratory syncytial virus (RSV)-specific monoclonal antibody palivizumab, the IMpact-RSV Study Group demonstrated a reduction in hospitalizations for RSV-related lower respiratory tract infection in infants who received prophylaxis compared with infants who did not receive prophylax...
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pub_type: 杂志文章
doi:10.1016/S0149-2918(00)88326-5
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
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journal_title:Clinical therapeutics
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doi:
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更新日期:2019-11-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2010-12-01 00:00:00
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pub_type: 杂志文章,多中心研究
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pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract::The field of rheumatology has made major contributions to medicine through the identification of cellular and molecular targets and with the development of therapies for the treatment of an impressive range of immune-mediated rheumatic diseases. In recent years new milestones have been achieved. These include the reco...
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更新日期:2019-07-01 00:00:00
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pub_type: 杂志文章
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更新日期:2017-03-01 00:00:00