Abstract:
BACKGROUND:A sprinkle capsule formulation containing enteric-coated, delayed-release rabeprazole granules is being developed for the treatment of children with gastrointestinal reflux disease. The granules are designed to be mixed with vehicles that facilitate delivery to children, who may be unable to swallow solid formulations. OBJECTIVE:The primary objective of this study-conducted on the sponsor's initiative-was to compare the bioavailability of rabeprazole granules when mixed with various dosing vehicles (small amount of soft food or infant formula) with that of a rabeprazole suspension with inactive vehicle granules (reference), to determine which dosing vehicle can be used to deliver rabeprazole in children. Tolerability was also assessed. METHODS:This single-center, single-dose, randomized, open-label, 5-period crossover study was conducted in 35 healthy adult subjects. In a randomized sequence, fasting subjects received a single dose of 10-mg rabeprazole granules per treatment period, mixed with small amounts of 1 of 5 dosing vehicles (a strawberry-flavored suspension of rabeprazole granules with inactive vehicle granules reconstituted with water, yogurt [1 tablespoon], applesauce [1 tablespoon], or infant formula [5 mL], or a suspension of rabeprazole granules with inactive vehicle tablet reconstituted with water). Full plasma pharmacokinetic (PK) profiles of rabeprazole and its thioether metabolite were collected; concentrations were estimated via LC-MS/MS. PK properties were estimated using noncompartmental methods; 90% CIs around least squares mean test-to-reference ratios were calculated for C(max) and AUC values. All treatment-emergent adverse events (TEAEs) were recorded and assessed for severity (mild, moderate, or severe) and relationship to study drug. RESULTS:A total of 35 subjects were enrolled (mean age, 38 years; 54.3% female; 100% white; mean weight, 71.4 kg). Thirty-four subjects completed the study. Rabeprazole and rabeprazole thioether plasma PK properties were comparable between all of the dosing vehicles tested. Median T(max) was 2.5 to 3.0 hours, and mean elimination half-life was 1.27 to 1.43 hours. The 90%CIs for the least squares mean ratios for rabeprazole and rabeprazole thioether exposure were within the 80% to 125% bioequivalence limits for all relevant comparisons. All TEAEs were of mild or moderate intensity, with headache being the most commonly reported; 21 subjects (60%) experienced TEAEs during the study. No deaths or serious AEs were reported during the study; 1 subject experienced a TEAE (urinary tract infection) that led to the discontinuation of treatment. CONCLUSION:In these healthy adult subjects, the bioavailability of rabeprazole granules was comparable between all of the dosing vehicles tested, and rabeprazole was well tolerated. Soft food suitable for young children or infant formula may be appropriate for use as dosing vehicles for rabeprazole granules.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Thyssen A,Solanki B,Treem Wdoi
10.1016/j.clinthera.2012.06.008subject
Has Abstractpub_date
2012-07-01 00:00:00pages
1636-45issue
7eissn
0149-2918issn
1879-114Xpii
S0149-2918(12)00371-2journal_volume
34pub_type
杂志文章,随机对照试验abstract:BACKGROUND:Therapeutic drug monitoring (TDM) is essential to maintain the efficacy of many immunosuppressant drugs while minimizing their toxicity. TDM has become more refined with the development of new monitoring techniques and more specific assays. OBJECTIVE:This article summarizes current data on TDM of the follow...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(02)85038-x
更新日期:2002-03-01 00:00:00
abstract::The effects of treatment with epalrestat, an aldose reductase inhibitor, on peripheral neuropathy were studied in 45 patients with non-insulin-dependent diabetes mellitus (NIDDM). Epalrestat 150 mg three times daily was given for 24 weeks. Subjective symptoms, such as spontaneous pain in the lower extremities and numb...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/0149-2918(95)80111-1
更新日期:1995-05-01 00:00:00
abstract::Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid family with demonstrated efficacy in the treatment of rheumatoid arthritis and osteoarthritis; a distinguished safety profile; and good tolerability. This report describes a new extended-release formulation that maintains therapeutic pla...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1994-03-01 00:00:00
abstract:BACKGROUND:Although third mandibular molar extraction is a widely used and validated model of acute pain for evaluating analgesic efficacy, a large proportion of patients experience moderate or severe pain following this procedure and require analgesia. Current treatment options have been associated with safety concern...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2012.01.004
更新日期:2012-02-01 00:00:00
abstract:PURPOSE:Despite the rapid proliferation of hyaluronate (HA) and corticosteroid (CO) injections and clinical guidelines regarding their use in osteoarthritis (OA), information on the characteristics of people receiving these injections is scarce. We describe the use of injections among adults with radiographically confi...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.01.006
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND:Hypertension usually clusters with other cardiovascular risk factors; however, it has not been reported whether hypertension treatment has an impact on the awareness and treatment of other cardiovascular risk factors such as diabetes mellitus and hypercholesterolemia. OBJECTIVE:To analyze the effect of hype...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2012.05.006
更新日期:2012-07-01 00:00:00
abstract::The objective of this 12-week, double-masked, randomized, multicenter study was to compare the elastoviscous properties of a high-molecular-weight viscosupplement, hylan G-F 20 (polymer concentration, 0.8%), with those of a lower-molecular-weight hyaluronan (LMW HA) product (polymer concentration, 1%) and to determine...
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:10.1016/s0149-2918(00)80010-7
更新日期:1999-09-01 00:00:00
abstract:BACKGROUND:In patients with type 2 diabetes, published data suggest that glycemic control can be achieved as effectively with an inhaled insulin regimen (preprandial inhaled intrapulmonary insulin plus a single bedtime Ultralente injection) as with a conventional subcutaneous insulin regimen involving 2 to 3 injections...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(02)85131-1
更新日期:2002-04-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to test the ability of human insulin 70/30, insulin lispro mixture 75/25 (75% neutral protamine lispro [NPL], 25% insulin lispro), and insulin lispro mixture 50/50 (50% NPL, 50% insulin lispro) to control postprandial glucose (PPG) concentrations in patients with type 2 diabetes mell...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2006.10.017
更新日期:2006-10-01 00:00:00
abstract::A single-blind comparison was undertaken to evaluate 250 mg of cinoxacin and 100 mg of nitrofurantoin, both drugs being given four times a day, for the treatment of urinary tract infections. Complete data are available from 58 patients, most of whom were treated for 10 to 15 days. The clinical response was similar in ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1982-01-01 00:00:00
abstract::To optimize the efficacy of radiotherapy for cancer patients who are pregnant, the following factors must be considered: the potential effects of the therapy on fetuses and neonates, the stage and prognosis of the mother's disease, and the possible risks to the patient of restricting cancer treatment. Malformations an...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(97)80101-4
更新日期:1997-07-01 00:00:00
abstract::Calorie/protein malnutrition is a common problem among dialysis patients. A study was designed to determine the value of adding a mixture of amino acids to the diet of 36 patients (mean age, 42 years) who had been receiving triweekly hemodialysis for periods ranging from 1 to 13 years. For 1 month the patients receive...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1993-07-01 00:00:00
abstract::A total of 804 pediatric patients (572 neonates and 232 infants and children) with suspected or documented serious infections were enrolled in a multicenter open study of netilmicin, a new semisynthetic aminoglycoside. All patients were evaluable for safety; 161 (20%) had bacteriologically documented infections and we...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1983-01-01 00:00:00
abstract:PURPOSE:The initiation of enzyme-replacement therapy prior to the occurrence of substantial and irreversible organ damage in patients with Fabry disease is of critical importance. The Fabry Outcome Survey is an international disease registry of patients with a confirmed diagnosis of Fabry disease. In this study, data f...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2020.10.007
更新日期:2020-12-01 00:00:00
abstract:OBJECTIVE:The objectives of this study were to observe a commercially insured sample diagnosed with a venous thromboembolism (VTE) event and treated postevent with warfarin and to detail the thromboembolic and bleeding outcomes in the time periods during warfarin therapy and after discontinuation of such therapy. METH...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(04)90187-7
更新日期:2004-07-01 00:00:00
abstract:BACKGROUND:Alzheimer's disease (AD) is estimated to affect up to 11% of those aged > or =65 years in the United States, and the number of patients with AD is predicted to increase over the next few decades as the population ages. The substantial social and economic burden associated with AD is well established, with th...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(03)80171-6
更新日期:2003-06-01 00:00:00
abstract::This paper explores how one health care purchasing coalition in Minnesota, the Buyers Health Care Action Group (BHCAG), has taken an active role in restructuring its local health care market. BHCAG started with the belief that the consumer should be the motivating force in health care delivery. Unfortunately, providin...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1997-11-01 00:00:00
abstract:BACKGROUND:Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality. Published practice guidelines and treatment algorithms for COPD are designed to increase awareness of the problem and improve patient care; however, <40% of subjects diagnosed with COPD are receiving appropri...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.10.006
更新日期:2007-10-01 00:00:00
abstract::The subjects were 20 chronic schizophrenic patients with dyslipidemia (total cholesterol levels greater than or equal to 220 mg/dl, triglycerides greater than or equal to 150 mg/dl, or high-density lipoprotein cholesterol less than or equal to 40 mg/dl) who had been receiving neuroleptics for a mean of ten years. Each...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1990-05-01 00:00:00
abstract::A comparison of single-agent antimicrobial therapy in the treatment of patients with perforated or gangrenous appendicitis and peritonitis was performed in a double-blind, randomized, prospective trial. Pathologic documentation of advanced appendicitis and positive intraoperative specimen cultures were required for in...
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:BACKGROUND:Mirodenafil is a phosphodiesterase type 5 (PDE-5) inhibitor developed for the treatment of erectile dysfunction. Mirodenafil has the possibility of being administered with alcohol. OBJECTIVE:This study assessed the hemodynamic effects and pharmacokinetic properties of mirodenafil administered with alcohol. ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.06.008
更新日期:2009-06-01 00:00:00
abstract:PURPOSE:This article focuses on 10 case studies of companies/organizations that are part of the current innovation ecosystem of regenerative medicine (RM) in the United Kingdom. It analyzes the actors, linkages, and influences that will determine the future shape of the RM industry sector and its capacity to live up to...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2018.06.003
更新日期:2018-07-01 00:00:00
abstract:OBJECTIVE:The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen ...
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:10.1016/s0149-2918(04)90055-0
更新日期:2004-04-01 00:00:00
abstract::This commentary reviews the difficulties in formulating oral products for children. The significance of the fragmentation of the pediatric population in terms of development and ability to ingest different dosage formulations is examined. It is postulated that a flexible formulation, acceptable by all patient groups, ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2014.01.010
更新日期:2014-02-01 00:00:00
abstract:BACKGROUND:Short-term studies have demonstrated a modest weight-reducing to weight-neutral effect among patients receiving bupropion sustained-release (SR) for the treatment of depression. OBJECTIVE:This study was conducted to evaluate the long-term effects of bupropion SR on body weight in patients with depression. ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(02)85141-4
更新日期:2002-04-01 00:00:00
abstract:BACKGROUND:Patients' adherence to antiosteoporotic drug therapy is essential to prevent fracture and complications of osteoporosis over the long term. The guidance given in treating osteoporosis can potentially enhance adherence. OBJECTIVE:This study was conducted to compare adherence to osteoporosis regimens by patie...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.05.019
更新日期:2013-07-01 00:00:00
abstract::In this open-label, randomized, cross-over study, 12 healthy subjects received four doses of a new sustained-release formulation of diltiazem hydrochloride for six consecutive days. Blood samples were drawn on days 5 and 6 for determination of plasma diltiazem and desacetyldiltiazem levels. The peak concentrations aft...
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:1992-03-01 00:00:00
abstract::Absorption of elemental iron from three single-daily-dose prenatal multivitamin/multimineral supplements was compared in bioavailability studies of subjects under fasting and postprandial conditions. Each of the supplements (Stuartnatal 1 + 1, Stuart Prenatal, and Materna 1.60) contained 60 or 65 mg of iron. The subje...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1988-01-01 00:00:00
abstract:BACKGROUND:Moxifloxacin is a fluoroquinolone antimicrobial agent with proven efficacy against community-acquired respiratory pathogens. Common adverse effects associated with its use include gastro-intestinal symptoms, but nephrotoxicity has not yet been reported to the manufacturer or in the literature (based on a MED...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2005.08.008
更新日期:2005-08-01 00:00:00
abstract:PURPOSE:The purpose of this study was to compare the bioavailability between 2 milk thistle-containing dietary supplements, Product B and IsaGenesis, in healthy volunteers. METHODS:Bioavailability between Product B, originally formulated as a powdered capsule, and IsaGenesis, reformulated as a soft gel, were compared ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2017.11.013
更新日期:2018-01-01 00:00:00