Abstract:
OBJECTIVE:Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved generic product Nulecit (generic SFG) and the branded product Ferrlecit (branded SFG) are bioequivalent. METHODS:In this open-label study, 240 healthy volunteers in a fasting state were assigned randomly to a single 10-min intravenous (IV) infusion of 125 mg of generic or branded SFG. Total and transferrin-bound iron concentrations were determined for the 36-h period after infusion and corrected for pretreatment levels. Maximum concentration (Cmax) and area under the concentration-time curve of 0 to 36 h (AUC[0-36]) were compared between the two products. Demonstration of bioequivalence required that the 90% confidence intervals of each parameter evaluated for generic SFG were within 80% to 125% of the corresponding values for branded SFG. RESULTS:Uncorrected and baseline-corrected mean serum concentrations of total serum iron during the 36-h assessment period were similar for generic and branded SFG. For total serum iron, the geometric mean ratios of corrected Cmax and AUC[0-36] were 100%. For transferrin-bound iron, the geometric mean ratios were 87% for corrected Cmax and 92% for corrected AUC[0-36]. All associated 90% confidence intervals were within the range of 80% to 125%. CONCLUSIONS:A new generic SFG in complex for IV infusion is bioequivalent to the branded SFG in complex for IV infusion. The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the branded product.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Baribeault Ddoi
10.1185/03007995.2011.597738subject
Has Abstractpub_date
2011-08-01 00:00:00pages
1653-7issue
8eissn
0300-7995issn
1473-4877journal_volume
27pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:To determine the ability of statins to prevent the development of new-onset type 2 diabetes mellitus through a meta-analysis of randomized, controlled trials. RESEARCH DESIGN AND METHODS:A systematic literature search through November 6, 2007 was conducted to identify randomized, placebo-controlled trials of...
journal_title:Current medical research and opinion
pub_type: 信件,评审
doi:10.1185/030079908x292029
更新日期:2008-05-01 00:00:00
abstract::Although the statistical strength of direct comparative randomized controlled trials is generally acknowledged, the particular demands of therapeutic decision making will often require indirect comparisons to be made, based on pooled data from multiple trials. As for all post-hoc analyses, the process of indirect comp...
journal_title:Current medical research and opinion
pub_type: 社论
doi:10.1185/03007995.2014.1002559
更新日期:2015-02-01 00:00:00
abstract:OBJECTIVES:This survey explores how physicians perceive chronic non-cancer pain, and examines their opinions on current treatment options. METHODOLOGY:The computer-based survey comprises a questionnaire that is completed by physicians, mostly at professional conferences and congresses, but also online. The focus is on...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2012.674499
更新日期:2012-05-01 00:00:00
abstract::A double-blind trial was carried out in 37 patients with osteoarthrosis to compare the efficacy and tolerance of 250 mg diflunisal twice daily with that of 400 mg ibuprofen 3-times daily over an 8-week period. Rating scale assessments were made, at the end of a preceding 1-week, wash-out period on placebo and at regul...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997809109001
更新日期:1978-01-01 00:00:00
abstract::Objective: The purpose of this study was to examine surgical and survival outcomes in the elderly (65-79 years of age) and the very elderly (≥80 years of age) who received surgery for gastric cancer.Methods: This study retrospectively reviewed the records of patients ≥65 years old who received a gastrectomy for gastri...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1520083
更新日期:2020-02-01 00:00:00
abstract:OBJECTIVE:Clinical evidence supports the use of cardiac resynchronization therapy (CRT) in advanced heart failure, but its cost-effectiveness is still unclear. This analysis assessed the economic and health consequences in the UK of implanting a CRT in patients with NYHA class III-IV heart failure. METHODS:A discrete ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X112516
更新日期:2006-06-01 00:00:00
abstract:AIMS:The safety and efficacy of exenatide BID (exenatide) and insulin glargine (glargine) have been studied in clinical trials with few elderly patients. This study examined the clinical effectiveness of exenatide compared to glargine in patients 65 years and older with type 2 diabetes mellitus (T2DM). METHODS:A retro...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2012.686901
更新日期:2012-06-01 00:00:00
abstract:OBJECTIVE:To compare the safety and efficacy of celecoxib versus diclofenac slow release (SR) plus omeprazole in elderly arthritis patients. RESEARCH DESIGN AND METHODS:Patients aged≥65 years, with osteoarthritis and/or rheumatoid arthritis, at high gastrointestinal (GI) risk who participated in the CONDOR trial (Cele...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2012.717528
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:In clinical practice, persistence with statin therapy is poor. While little is known about relative persistence to specific statins, previous studies have observed greater persistence in patients who achieve greater degrees of lipid lowering. Identification of statin therapies which improve patient persisten...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802203279
更新日期:2008-07-01 00:00:00
abstract:OBJECTIVE:To conduct a preliminary evaluation of a new oral formulation of controlled-release (CR) oxybutynin tablet taken once-daily in patients with urinary urge incontinence. RESEARCH DESIGN AND METHODS:A single-centre, open-label, 8-week study was conducted. Patients with urodynamically-confirmed detrusor instabil...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/030079903125002955
更新日期:2004-01-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to quantify the incidence of thromboembolic events (specifically, deep vein thromboses [DVT] and pulmonary embolism [PE]) in patients with cancer, and to examine the effects of a major clinical trial design and execution factors on those incidence rates. RESEARCH DESIGN AND ME...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1185/030079908x261050
更新日期:2008-02-01 00:00:00
abstract::Objective: Hypertension is a serious health problem in Egypt, with prevalence rate of 17% as reported in 2015. Despite receiving treatment, many do not achieve blood pressure (BP) control. The current study aimed to evaluate the efficacy and tolerability of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) singl...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1719394
更新日期:2020-04-01 00:00:00
abstract::In a double-blind trial in 26 patients with symptomatic gastro-oesophageal reflux, the alginate/effervescent/antacid compound 'Gaviscon' was compared with antacid containing placebo similarly formulated. Retrosternal pain after meals and at night was significantly reduced whilst patients were taking 'Gaviscon' and the...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997509114793
更新日期:1975-01-01 00:00:00
abstract::All the components of the kallikrein-kinin system are located in the vascular smooth muscle as well as in the heart. In recent years, numerous observations obtained from clinical and experimental models of diabetes, hypertension, cardiac failure, ischaemia, myocardial infarction and left ventricular hypertrophy, have ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990212500093
更新日期:2002-01-01 00:00:00
abstract:OBJECTIVE:Based on the clear neuroanatomical delineation of many neuropathic pain (NP) symptoms, a simple tool for performing a short structured clinical encounter based on the IASP diagnostic criteria was developed to identify NP. This study evaluated its accuracy and usefulness. METHODS:A case-control study was perf...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1465905
更新日期:2018-08-01 00:00:00
abstract::Zolmitriptan has been developed in an orally disintegrating tablet (ODT) formulation that rapidly dissolves on the tongue and can be taken quickly, conveniently and discreetly without fluid intake. In this 3-month, non-comparative, observational, post-marketing surveillance (PMS) study, 5,570 physicians prescribed the...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X46296
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the clinical efficacy and safety of mometasone furoate administered via a dry powder inhaler (MF-DPI) in Japanese patients with intermittent or mild persistent asthma who were not previously receiving inhaled corticosteroids. RESEARCH DESIGN AND METHODS:This was an 8-week open-label study conduct...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990903422380
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:In order to reduce individual cardiovascular risk, many patients require life-long lipid-lowering therapy, often as a drug combination approach. We aimed to describe the usage pattern, effectiveness and tolerability of long-term treatment with lipid-lowering agents, with particular focus on an oral combinati...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/03007990802381406
更新日期:2008-10-01 00:00:00
abstract::The pharmacokinetics of Bay g 2821, a new diuretic agent, were studied in dogs, healthy volunteers and in patients with renal insufficiency. The drug was rapidly absorbed after oral administration, peak plasma levels (approx. 0.4 microgram/ml) occurring within 1 hour. Elimination of the unchanged drug from plasma was ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997709115271
更新日期:1977-01-01 00:00:00
abstract:INTRODUCTION AND OBJECTIVE:As evidence grows about the management of hyponatremia, a number of different international and national recommendations/guidelines from professional organizations have recently been published that offer guidance on decision-making. However, they include several important differences that cou...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2014.920314
更新日期:2014-07-01 00:00:00
abstract:OBJECTIVE:The stratum corneum (SC) pharmacokinetics of terbinafine following single-dose administration of a novel cutaneous solution (film-forming solution, FFS) containing terbinafine hydrochloride and a film-forming agent, was investigated in three studies. Terbinafine 1% cream (Lamisil) was included as a benchmark ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/030079907X199664
更新日期:2007-06-01 00:00:00
abstract:OBJECTIVE:Implantation of bone marrow mononuclear cells (BM-MNCs), including endothelial progenitor cells, into ischemic lower limbs has been shown to improve symptoms in patients with peripheral arterial diseases (PAD). This study investigated whether BM-MNC implantation (BMI) is also effective for the ischemic hands ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X1000078
更新日期:2006-04-01 00:00:00
abstract::A single-blind, between-patient comparative study was carried out in general practice to assess the effectiveness of antacid plus antispasmodic combination tablets (240 mg dried aluminium hydroxide B.P., 144 mg magnesium hydroxide B.P.C., and 5 mg dicyclomine hydrochloride B.P.) and aluminium hydroxide B.P. tablets (5...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997709110165
更新日期:1977-01-01 00:00:00
abstract:OBJECTIVES:To compare retinal thickness before and after treatment with the fluocinolone acetonide (FAc) 190 µg intravitreal implant in people with diabetic macular edema (DME) using data from the Iluvien Clinical Evidence study in the UK (ICE-UK). METHODS:For this retrospective cohort study, data on people attending ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1366662
更新日期:2017-10-01 00:00:00
abstract::A double-blind, crossover trial was carried out in 40 in-patients with gastro-intestinal spasmodic syndromes to compare the effectiveness and tolerance of fenoverine and trimebutine. Patients were allocated at random to receive either 100 mg fenoverine or 150 mg trimebutine 3-times daily for 20 days and were then cros...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998609111090
更新日期:1986-01-01 00:00:00
abstract::An open, controlled study was carried out in 30 in-patients with low arterial pressure syndrome to compare the effectiveness and tolerance of dimetophrine and midodrine in restoring blood pressure to normal levels and relieving symptoms. Patients were allocated at random to receive treatment for 15 days with either 10...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998409109590
更新日期:1984-01-01 00:00:00
abstract::Amlodipine, a dihydropyrimidine calcium antagonist, is effective in the treatment of patients with mild to moderate hypertension at doses of 5-10 mg daily. The aim of the study reported here was to determine whether an early increase in dosage of amlodipine provided an advantage in terms of antihypertensive effect. Th...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999909115172
更新日期:1999-01-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to evaluate the safety and clinical efficacy of alcaftadine 0.25% ophthalmic solution, a new topical anti-allergic agent for the prevention of the signs and symptoms of allergic conjunctivitis induced by conjunctival allergen challenge (CAC). STUDY DESIGN AND METHODS:This two-ar...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2010.548797
更新日期:2011-03-01 00:00:00
abstract:BACKGROUND:Patients with chronic myeloid leukemia (CML) who do not adhere to treatment may experience suboptimal outcomes. OBJECTIVE:To examine the association between adherence with imatinib and direct healthcare costs and resource utilization in a large group of privately insured CML patients. PATIENTS AND METHODS:...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990903396469
更新日期:2010-01-01 00:00:00
abstract:OBJECTIVE:Despite a plethora of published data on levocetirizine, no meta-analyses exist on the effect of study design, and covariates like age, gender, and baseline symptom severity on treatment response. The objective of this study was the efficacy of levocetirizine 5 mg tablets and matching placebo at reducing alle...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/03007995.2010.537319
更新日期:2011-01-01 00:00:00