abstract：:Understanding how inhibition of cytochrome P4503A (CYP3A) affects the metabolism of a new drug is critical in determining if a clinically relevant drug interaction will occur. Diltiazem interaction studies assess a given compound's sensitivity to moderate CYP3A inhibition. The present study compared the effect differe...

journal_title：Journal of clinical pharmacology

authors： Friedman EJ,Fraser IP,Wang YH,Bergman AJ,Li CC,Larson PJ,Chodakewitz J,Wagner JA,Stoch SA

更新日期：2011-11-01 00:00:00

abstract：:To explore the clinical relevance of inhibition of multidrug resistance transporter 1 and organic anion transporting polypeptide transporter, a drug-drug interaction study was conducted using aliskiren and cyclosporine. This was an open-label, single-sequence, parallel-group, single-dose study in healthy subjects. Sub...

journal_title：Journal of clinical pharmacology

authors： Rebello S,Compain S,Feng A,Hariry S,Dieterich HA,Jarugula V

更新日期：2011-11-01 00:00:00

abstract：:The angiotensin-converting enzyme (ACE) gene is a candidate genetic locus for coronary artery disease (CAD). Studies investigating the relationship between the ACE-insertion/deletion (I/D) gene polymorphism and myocardial infarction (MI) have been inconsistent. The authors hypothesized that age may be an important mod...

journal_title：Journal of clinical pharmacology

authors： Hamelin BA,Zakrzewski-Jakubiak M,Robitaille NM,Bogaty P,Labbé L,Turgeon J

更新日期：2011-09-01 00:00:00

abstract：:The study evaluated whether a liquid suspension of adefovir dipivoxil (ADV) is effective and safe when dose adjusted based on varying degrees of renal impairment in patients with chronic hepatitis B. Patients had stable mild, moderate, or severe renal impairment or end-stage renal disease. Twenty-eight patients were e...

journal_title：Journal of clinical pharmacology

authors： Shiffman ML,Pol S,Rostaing L,Schiff E,Thabut D,Zeuzem S,Zong J,Frederick D,Rousseau F

更新日期：2011-09-01 00:00:00

abstract：:Thrombomodulin alfa is the recombinant extracellular domain of human thrombomodulin, which shows anticoagulation activity. To elucidate the pharmacokinetics of thrombomodulin alfa in patients with disseminated intravascular coagulation (DIC), population pharmacokinetic (PPK) analysis was performed using plasma concent...

journal_title：Journal of clinical pharmacology

authors： Tsuruta K,Yamada Y,Serada M,Tanigawara Y

更新日期：2011-09-01 00:00:00

abstract：:Interactions between tolvaptan and digoxin were determined in an open-label, sequential study where 14 healthy subjects received tolvaptan 60 mg once daily (QD) on days 1 and 12 to 16 and digoxin 0.25 mg QD on days 5 to 16. Mean maximal concentrations (C(max)) and area under the curve during the dosing interval (AUC(τ...

journal_title：Journal of clinical pharmacology

authors： Shoaf SE,Ohzone Y,Ninomiya S,Furukawa M,Bricmont P,Kashiyama E,Mallikaarjun S

更新日期：2011-05-01 00:00:00

abstract：:This study was designed to investigate the multiple-dose pharmacokinetics, safety, and tolerability of the selective α4β2 nicotinic acetylcholine partial agonist, varenicline, in elderly (65-85 years old) nonsmokers. Fifty male and female subjects with normal renal function for their age were randomized to receive var...

journal_title：Journal of clinical pharmacology

authors： Zhao Q,Schwam E,Fullerton T,O'Gorman M,Burstein AH

更新日期：2011-04-01 00:00:00

abstract：:The population pharmacokinetic (PK) profile of oral clonidine was characterized in newborns with neonatal abstinence syndrome, and significant covariates affecting its PK parameters were identified. Plasma clonidine concentration data were obtained from a clinical trial in which 36 newborns, aged 1 to 25 days (postnat...

journal_title：Journal of clinical pharmacology

authors： Xie HG,Cao YJ,Gauda EB,Agthe AG,Hendrix CW,Lee H

更新日期：2011-04-01 00:00:00

abstract：:Comparative pharmacokinetics of vitamin K epoxide reductase antagonists tecarfarin and warfarin were assessed before and after coadministration for 21 days of the CYP450 inhibitor fluconazole in a randomized, open-label, single-center drug interaction study. Twenty healthy adult participants were randomized 1:1 to rec...

journal_title：Journal of clinical pharmacology

authors： Bavisotto LM,Ellis DJ,Milner PG,Combs DL,Irwin I,Canafax DM

更新日期：2011-04-01 00:00:00

abstract：:Varenicline is a novel selective α4β2 nicotinic acetylcholine partial agonist developed for smoking cessation. Single- and multiple dose studies were conducted to investigate pharmacokinetics, safety, and tolerability of varenicline in healthy male Japanese smokers. The single-dose study was conducted as a double-blin...

journal_title：Journal of clinical pharmacology

authors： Kikkawa H,Maruyama N,Fujimoto Y,Hasunuma T

更新日期：2011-04-01 00:00:00

abstract：:The purpose of this open-label, parallel-group study was to investigate the effect of severe renal impairment on the pharmacokinetics (PK), tolerability, and safety of clazosentan, an intravenous endothelin receptor antagonist. Clazosentan was administered as a continuous intravenous infusion of 1 mg/h for a period of...

journal_title：Journal of clinical pharmacology

authors： Bruderer S,Sasu B,Tsvitbaum N,Dingemanse J

更新日期：2011-03-01 00:00:00

abstract：:The objectives of the 3 phase I studies described herein were (1) to compare the pharmacokinetics of gabapentin delivered from a novel gastric-retentive dosage form vs an immediate-release formulation, (2) to assess the dose proportionality of the gastric-retentive extended-release formulation, and (3) to determine th...

journal_title：Journal of clinical pharmacology

authors： Chen C,Cowles VE,Hou E

更新日期：2011-03-01 00:00:00

abstract：:Atazanavir, a potent protease inhibitor of human immunodeficiency virus (HIV), exhibits pH-dependent solubility. Previous studies have indicated that coadministration with omeprazole 40 mg once daily significantly decreased atazanavir exposure by approximately 75%. Concomitant use of omeprazole and atazanavir is curre...

journal_title：Journal of clinical pharmacology

authors： Zhu L,Persson A,Mahnke L,Eley T,Li T,Xu X,Agarwala S,Dragone J,Bertz R

更新日期：2011-03-01 00:00:00

abstract：:This was a double-blind, placebo-controlled, randomized, parallel, dose-escalation study to assess the pharmacokinetics, platelet response, safety, and tolerability of supratherapeutic doses of eltrombopag (100 mg, 150 mg, and 200 mg once daily) administered for 5 days to 33 healthy adult volunteers. Plasma eltrombopa...

journal_title：Journal of clinical pharmacology

authors： Matthys G,Park JW,McGuire S,Wire MB,Bowen C,Williams D,Jenkins J,Peng B

更新日期：2011-03-01 00:00:00

abstract：BACKGROUND:L-threo-3,4-dihydroxyphenylserine (L-DOPS), a norepinephrine (NE) prodrug, is investigational for orthostatic hypotension, which occurs commonly in Parkinson's disease. Adjunctive anti-parkinsonian drugs might interact with L-DOPS. We tested whether L-aromatic amino-acid decarboxylase inhibition by carbidopa...

journal_title：Journal of clinical pharmacology

authors： Goldstein DS,Holmes C,Sewell L,Pechnik S,Kopin IJ

更新日期：2011-01-01 00:00:00

abstract：:Gender and body weight influence the pharmacokinetics and pharmacodynamics of many drugs. This pooled analysis of 17 clinical studies evaluated the effect of gender, body mass index (BMI), body weight, and lean body weight (LBW) on the pharmacokinetics of the direct renin inhibitor aliskiren in healthy volunteers (n =...

journal_title：Journal of clinical pharmacology

authors： Jarugula V,Yeh CM,Howard D,Bush C,Keefe DL,Dole WP

更新日期：2010-12-01 00:00:00

abstract：:The objective of this study was to evaluate the effect of the antireflux barrier formed by Na alginate on pH-metry-defined acid reflux events in preterms. Four times/day, 1 mL/kg of Na alginate was administered as an intervention to the preterm infants whose gastroesophageal reflux disease was confirmed by 24-hour pH ...

journal_title：Journal of clinical pharmacology

authors： Atasay B,Erdeve O,Arsan S,Türmen T

更新日期：2010-11-01 00:00:00

abstract：:Moxifloxacin is used in thorough QT studies to assess sensitivity for detection of an increase in QTc. Moxifloxacin is usually over-encapsulated for blinding. However, there is concern that over-encapsulation alters its pharmacokinetics. In a 4-arm, randomized crossover study, 22 volunteers received over-encapsulated ...

journal_title：Journal of clinical pharmacology

authors： Mason JW,Florian JA Jr,Garnett CE,Moon TE,Selness DS,Spaulding RR

更新日期：2010-11-01 00:00:00

abstract：:This study assessed the efficacy and safety of ketoprofen patch compared with placebo in patients who had rheumatoid arthritis and persistent wrist pain. Patients (N = 676)who had achieved systemic disease control with a disease-modifying antirheumatic drug and/or systemic corticosteroid, but still had persistent wris...

journal_title：Journal of clinical pharmacology

authors： Kawai S,Uchida E,Kondo M,Ohno S,Obata J,Nawata Y,Sugimoto K,Oribe M,Nagaya I

更新日期：2010-10-01 00:00:00

abstract：:Desirudin is a renally eliminated direct thrombin inhibitor approved to prevent venous thromboembolism. Empiric dosage adjustment and activated partial thromboplastin time (aPTT) monitoring in patients with moderate renal impairment are recommended, but supportive data are lacking. The objective of this study was to e...

journal_title：Journal of clinical pharmacology

authors： Nafziger AN,Bertino JS Jr

更新日期：2010-06-01 00:00:00

abstract：:The objective of this study was to investigate the gene expression signature of monocyte/macrophages and the pleiotropic effects of atorvastatin on monocytes in atherosclerotic patients. Forty patients with coronary heart diseases were randomly assigned to double-blind therapy with either 20 or 80 mg per day of atorva...

journal_title：Journal of clinical pharmacology

authors： Wang ZH,Liu XL,Zhong M,Zhang LP,Shang YY,Hu XY,Li L,Zhang Y,Deng JT,Zhang W

更新日期：2010-03-01 00:00:00

abstract：:The extension of the previously developed integrated models for glucose and insulin (IGI) to include the oral glucose tolerance test (OGTT) in healthy volunteers could be valuable to better understand the differences between healthy individuals and those with type 2 diabetes mellitus (T2DM). Data from an OGTT in 23 he...

journal_title：Journal of clinical pharmacology

authors： Silber HE,Frey N,Karlsson MO

更新日期：2010-03-01 00:00:00

abstract：:Ustekinumab, a human immunoglobulin G1 kappa (IgG1k) monoclonal antibody that binds with high affinity to human interleukin-12 and interleukin-23, has demonstrated efficacy in patients with psoriasis. The objective of this study was to perform exposure-response modeling to increase the understanding of reduction in di...

journal_title：Journal of clinical pharmacology

authors： Zhou H,Hu C,Zhu Y,Lu M,Liao S,Yeilding N,Davis HM

更新日期：2010-03-01 00:00:00

abstract：:Angiotensin-converting enzyme inhibitors are effective at reducing blood pressure, whereas statins decrease plasma cholesterol impeding atherosclerosis. It is hypothesized that these medications may improve blood pressure and serum cholesterol by modifying the antioxidative status and energy metabolism of erythrocytes...

journal_title：Journal of clinical pharmacology

authors： Kaminsky Y,Suslikov A,Kosenko E

更新日期：2010-02-01 00:00:00

abstract：:The effect of telbivudine on cardiac repolarization was evaluated in healthy participants at clinical and supratherapeutic doses. Sixty-two participants were enrolled, stratified by sex, and randomized according to a crossover design among 4 treatment sequences: placebo, a single moxifloxacin 400-mg dose as positive c...

journal_title：Journal of clinical pharmacology

authors： Poordad F,Zeldin G,Harris SI,Ke J,Xu L,Mayers D,Zhou XJ

更新日期：2009-12-01 00:00:00

abstract：:This study evaluated the pharmacodynamics and pharmacokinetics of once-daily dosing of warfarin at steady state when taken concomitantly with once-daily doses of duloxetine. Healthy subjects with a stable international normalized ratio (INR) of 1.5 to 2.0 on an individualized fixed dose of warfarin (2-9 mg) in period ...

journal_title：Journal of clinical pharmacology

authors： Chappell J,He J,Knadler MP,Mitchell M,Lee D,Lobo E

更新日期：2009-12-01 00:00:00

abstract：:The effect of the proton pump inhibitor dexlansoprazole, an enantiomer of lansoprazole, on QT intervals was assessed after oral administration of a modified-release formulation of dexlansoprazole (dexlansoprazole MR). In this randomized, positive-comparator, placebo-controlled, 4-period crossover study, 40 healthy par...

journal_title：Journal of clinical pharmacology

authors： Vakily M,Wu J,Atkinson SN

更新日期：2009-12-01 00:00:00

abstract：:The objective of this study was to establish effects of liraglutide on the QTc interval. In this randomized, placebo-controlled, double-blind crossover study, 51 healthy participants were administered placebo, 0.6, 1.2, and 1.8 mg liraglutide once daily for 7 days each. Electrocardiograms were recorded periodically ov...

journal_title：Journal of clinical pharmacology

authors： Chatterjee DJ,Khutoryansky N,Zdravkovic M,Sprenger CR,Litwin JS

更新日期：2009-11-01 00:00:00

abstract：:Sitagliptin is an orally active, highly selective dipeptidyl peptidase IV (DPP-4) inhibitor for treatment of type 2 diabetes mellitus. This randomized, open-label, 2-part, 2-period crossover study assessed pharmacokinetics/pharmacodynamics of warfarin in the presence/absence of multiple-dose sitagliptin. Twelve partic...

journal_title：Journal of clinical pharmacology

authors： Wright DH,Herman GA,Maes A,Liu Q,Johnson-Levonas AO,Wagner JA

更新日期：2009-10-01 00:00:00

abstract：:This study was designed to evaluate the steady-state pharmacokinetics (PK) of estradiol and its metabolites, estrone and estrone sulfate, following application of a novel estradiol transdermal spray to healthy postmenopausal women. Participants were randomly assigned in parallel to receive 1-, 2-, or 3-spray doses (24...

journal_title：Journal of clinical pharmacology

authors： Morton TL,Gattermeir DJ,Petersen CA,Day WW,Schumacher RJ

更新日期：2009-09-01 00:00:00

abstract：:Serial pharmacokinetic (PK) sampling in 1159 patients from TRITON-TIMI 38 was undertaken. A multilinear regression model was used to quantitatively predict prasugrel's active metabolite (Pras-AM) concentrations from its 2 downstream inactive metabolites. Population-based methods were then applied to Pras-AM concentrat...

journal_title：Journal of clinical pharmacology

authors： Wrishko RE,Ernest CS 2nd,Small DS,Li YG,Weerakkody GJ,Riesmeyer JR,Macias WL,Rohatagi S,Salazar DE,Antman EM,Wiviott SD,Braunwald E,Ni L

更新日期：2009-08-01 00:00:00

abstract：:Coronary heart disease, hypertension, and dyslipidemia are highly prevalent and commonly coexist in people who are middle-aged and older. Previous data suggested that lowering cholesterol concentrations in individuals at high risk of cardiovascular disease improved clinical outcomes. Xuezhikang, a partial extract of r...

journal_title：Journal of clinical pharmacology

authors： Li JJ,Lu ZL,Kou WR,Chen Z,Wu YF,Yu XH,Zhao YC,Chinese Coronary Secondary Prevention Study Group.

更新日期：2009-08-01 00:00:00

abstract：:This randomized crossover study in healthy participants assessed pharmacokinetic interactions between telavancin, aztreonam, and piperacillin/tazobactam. Part 1: 11 participants received telavancin 10 mg/kg, aztreonam 2 g, or a combination of telavancin 10 mg/kg+aztreonam 2 g intravenously on 3 separate days. Part 2: ...

journal_title：Journal of clinical pharmacology

authors： Wong SL,Sörgel F,Kinzig M,Goldberg MR,Kitt MM,Barriere SL

更新日期：2009-07-01 00:00:00

abstract：:Optimal design has been used in the past mainly to optimize sampling schedules for clinical trials. Optimization on design variables other than sampling times has been published in the literature only once before. This study shows, as an example, optimization on the length of treatment periods to obtain reliable estim...

journal_title：Journal of clinical pharmacology

authors： Hennig S,Nyberg J,Hooker AC,Karlsson MO

更新日期：2009-03-01 00:00:00

abstract：:In vitro data on the metabolism of the antifungal voriconazole suggest that its pharmacokinetics might be influenced by the activity of CYP2C19, CYP2C9, and CYP3A. To elucidate the genetic influence of polymorphic enzymes on voriconazole metabolism, the authors pooled the pharmacokinetic data from 2 interaction studie...

journal_title：Journal of clinical pharmacology

authors： Weiss J,Ten Hoevel MM,Burhenne J,Walter-Sack I,Hoffmann MM,Rengelshausen J,Haefeli WE,Mikus G

更新日期：2009-02-01 00:00:00

abstract：:Cyclophosphamide-based regimens are front-line treatment for numerous pediatric malignancies; however, current dosing methods result in considerable interpatient variability in tumor response and toxicity. In this pediatric population, the authors' objectives were (1) to quantify and explain the pharmacokinetic variab...

journal_title：Journal of clinical pharmacology

authors： McCune JS,Salinger DH,Vicini P,Oglesby C,Blough DK,Park JR

更新日期：2009-01-01 00:00:00

abstract：:ABT-335 is the choline salt of fenofibric acid under clinical development as a combination therapy with rosuvastatin for the management of dyslipidemia. ABT-335 and rosuvastatin have different mechanisms of actions and exert complementary pharmacodynamic effects on lipids. The current study assessed the pharmacokineti...

journal_title：Journal of clinical pharmacology

authors： Zhu T,Awni WM,Hosmane B,Kelly MT,Sleep DJ,Stolzenbach JC,Wan K,Chira TO,Pradhan RS

更新日期：2009-01-01 00:00:00

abstract：:The aim of this pharmacokinetic analysis was to develop and validate a population pharmacokinetic model for R- and S-ibuprofen from samples obtained after 3 successive administrations of ibuprofen (10-5-5 mg/kg) at 24-hour intervals to preterm newborn infants aged from <6 hours to 8 days of life. A model including uni...

journal_title：Journal of clinical pharmacology

authors： Gregoire N,Desfrere L,Roze JC,Kibleur Y,Koehne P

更新日期：2008-12-01 00:00:00

abstract：:This study investigated the potential pharmacokinetic interaction between the direct renin inhibitor aliskiren and modulators of P-glycoprotein and cytochrome P450 3A4 (CYP3A4). Aliskiren stimulated in vitro P-glycoprotein ATPase activity in recombinant baculovirus-infected Sf9 cells with high affinity (K(m) 2.1 micro...

journal_title：Journal of clinical pharmacology

authors： Vaidyanathan S,Camenisch G,Schuetz H,Reynolds C,Yeh CM,Bizot MN,Dieterich HA,Howard D,Dole WP

更新日期：2008-11-01 00:00:00

abstract：:The primary objective was to determine the pharmacokinetics of single oral and intravenous doses of pantoprazole in children 2 to 16 years of age. The secondary objective was to assess the safety and tolerability of these doses. Male and female hospitalized and nonhospitalized patients from ages 5 to 16 years received...

journal_title：Journal of clinical pharmacology

authors： Kearns GL,Blumer J,Schexnayder S,James LP,Adcock KG,Reed MD,Daniel JF,Gaedigk A,Paul J

更新日期：2008-11-01 00:00:00