Application of preclinical data to initiate the modified continual reassessment method for maximum tolerated dose-finding trials.

abstract：:The objective of this study was to determine the effects of double-strength grapefruit juice on gastric pH and systemic bioavailability of indinavir in HIV-infected subjects receiving indinavir. Fourteen HIV-infected subjects took 800 mg of indinavir with 6 ounces (180 ml) of water or double-strength grapefruit juice....

journal_title：Journal of clinical pharmacology

authors： Shelton MJ,Wynn HE,Hewitt RG,DiFrancesco R

更新日期：2001-04-01 00:00:00

abstract：:Concentrations in breast milk of medications used during general anesthesia were measured to determine whether interruption of breast-feeding was indicated. Breast milk and maternal blood samples were obtained from nine women undergoing tubal sterilization under general anesthesia. Concentrations of methohexital, mepe...

journal_title：Journal of clinical pharmacology

authors： Borgatta L,Jenny RW,Gruss L,Ong C,Barad D

更新日期：1997-03-01 00:00:00

abstract：:A method of estimating the elimination half-life of a drug at any selected serum concentration when the Km and Vmax of that drug are known is described. The method was validated in six patients by determining their Km and Vmax values for phenytoin, using data obtained at two serum concentrations and then using the Km ...

journal_title：Journal of clinical pharmacology

authors： Browne TR,Greenblatt DJ,Evans JE,Szabo GK,Evans BA,Schumacher GE

更新日期：1987-04-01 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：:CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a synergistic ratio, is approved in the United States for adults with newly diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes. Population pharmacokinetics analyses were performed ...

journal_title：Journal of clinical pharmacology

authors： Wang Q,Banerjee K,Vasilinin G,Marier JF,Gibbons JA

更新日期：2019-05-01 00:00:00

abstract：:Compared with aminoglycosides, chloramphenicol, sulfonamides, tetracyclines, and even penicillins, the cephalosporins represent a remarkably safe class of antibiotics. Among the cephalosporins, the extended spectrum, third generation agents developed generally produce few side effects and appear to be less allergenic ...

journal_title：Journal of clinical pharmacology

authors： Neu HC

更新日期：1990-05-01 00:00:00

abstract：:GS-9667, a new selective, partial agonist of the A(1) adenosine receptor (AR), may represent an effective therapy for Type 2 diabetes (T2DM) and dyslipidemia via lowering of free fatty acids (FFA). The objectives of the studies were to evaluate the effects of single and multiple doses of GS-9667 on plasma FFA concentr...

journal_title：Journal of clinical pharmacology

authors： Staehr PM,Dhalla AK,Zack J,Wang X,Ho YL,Bingham J,Belardinelli L

更新日期：2013-04-01 00:00:00

abstract：:Pharmacokinetics (PK) of doripenem was determined during high volume hemodiafiltration (HVHDF) in patients with septic shock. A single 500 mg dose of doripenem was administered as a 1 hour infusion during HVHDF to 9 patients. Arterial blood samples were collected before and at 30 or 60 minute intervals over 8 hours (1...

journal_title：Journal of clinical pharmacology

authors： Tamme K,Oselin K,Kipper K,Low K,Standing JF,Metsvaht T,Karjagin J,Herodes K,Kern H,Starkopf J

更新日期：2015-04-01 00:00:00

abstract：:There is an increasing interest in the simultaneous administration of several probe substrates to characterize the activity of multiple drug-metabolizing enzymes, the so-called "cocktail" approach. However, this method remains controversial and is being investigated more extensively. No general consensus has emerged o...

journal_title：Journal of clinical pharmacology

authors： Zhou H,Tong Z,McLeod JF

更新日期：2004-02-01 00:00:00

abstract：:A randomized, double-blind, within-patient, crossover study was carried out after bilateral "identical" surgical procedures using local anesthesia only. A 3-day tablet regime of racemic ketoprofen 75 mg or acetaminophen 1000 mg qid (x 4) was given starting 3 hours after surgery. Ketoprofen reduced objectively measured...

journal_title：Journal of clinical pharmacology

authors： Bjørnsson GA,Haanaes HR,Skoglund LA

更新日期：2003-03-01 00:00:00

abstract：:Transporters play an important role in drug absorption, disposition, and drug action. The evaluation of drug transporters requires a comprehensive understanding of transporter biology and pharmacology. Physiologically based pharmacokinetic (PBPK) models may offer an integrative platform to quantitatively evaluate the ...

journal_title：Journal of clinical pharmacology

authors： Pan Y,Hsu V,Grimstein M,Zhang L,Arya V,Sinha V,Grillo JA,Zhao P

更新日期：2016-07-01 00:00:00

abstract：:Numerous physiologic variations, including urinary protein excretion, low serum albumin concentrations, and reductions in kidney function (clearance), exist in patients with glomerulonephritis. These factors could alter the disposition of numerous drugs. The purpose of the current article was to review the influence o...

journal_title：Journal of clinical pharmacology

authors： Joy MS

更新日期：2012-01-01 00:00:00

abstract：:The pharmacokinetics and pharmacodynamics of verapamil were investigated in six chronic hemodialysis patients. A single oral 120-mg dose was administered both on a non-hemodialysis day and a hemodialysis day separated by greater than or equal to 7 days. Blood pressure and PR interval were measured simultaneously with ...

journal_title：Journal of clinical pharmacology

authors： Hanyok JJ,Chow MS,Kluger J,Izard MW

更新日期：1988-09-01 00:00:00

abstract：:Tafenoquine is being developed for relapse prevention in Plasmodium vivax malaria. This Phase I, single-blind, randomized, placebo- and active-controlled parallel group study investigated whether tafenoquine at supratherapeutic and therapeutic concentrations prolonged cardiac repolarization in healthy volunteers. Subj...

journal_title：Journal of clinical pharmacology

authors： Green JA,Patel AK,Patel BR,Hussaini A,Harrell EJ,McDonald MJ,Carter N,Mohamed K,Duparc S,Miller AK

更新日期：2014-09-01 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：: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：:Cannabinoids, including smoked marijuana and delta9-tetrahydrocannabinol (THC) (dronabinol, Marinol), have been used to treat human immunodeficiency virus-1 (HIV)-associated anorexia and weight loss. Concerns have been raised, however, that these compounds might have adverse effects on the immune system of subjects wi...

journal_title：Journal of clinical pharmacology

authors： Bredt BM,Higuera-Alhino D,Shade SB,Hebert SJ,McCune JM,Abrams DI

更新日期：2002-11-01 00:00:00

abstract：:This study aimed to investigate a food effect on the bio-availability of modified-release (MR) trimetazidine tablets in 36 healthy volunteers. Trimetazidine, an anti-ischemic drug, protects the myocardial cell from the harmful effects of ischemia. The authors investigated the effect of being under a fasting or fed sta...

journal_title：Journal of clinical pharmacology

authors： Ozbay L,Unal DO,Erol D

更新日期：2012-10-01 00:00:00

abstract：:The type II histamine receptor antagonists, cimetidine and ranitidine, widely used in treatment of peptic ulcer disease have been reported to cause bradycardia. To evaluate the cardiovascular effects of H2 antagonists nineteen healthy volunteers were entered into a double-blind crossover comparison of cimetidine 300 m...

journal_title：Journal of clinical pharmacology

authors： Hughes DG,Dowling EA,DeMeersman RE,Garnett WR,Karnes HT

更新日期：1989-05-01 00:00:00

abstract：:In the analysis of longitudinal pharmacokinetic data, both balanced (equal number of samples per subject) and unbalanced data are used. It is implicitly assumed that the process that caused the missing data can be ignored. A simulation study was performed to determine the effect of ignoring the missing data (i.e., "ig...

journal_title：Journal of clinical pharmacology

authors： Ette EI,Sun H,Ludden TM

更新日期：1998-03-01 00:00:00

abstract：:Calcium-channel blockers have been shown to be both safe and effective for treatment of patients with systemic hypertension. These drugs reduce peripheral vascular resistance predominantly by the inhibition of transmembrane calcium ion fluxes in vascular smooth muscle, and by this mechanism can reduce elevated blood p...

journal_title：Journal of clinical pharmacology

authors： Frishman WH,Landau A,Cretkovic A

更新日期：1993-08-01 00:00:00

abstract：:The effects of large doses of anabolic steroids on 24-hour blood pressure, cardiac structure and function, and lipid profiles were studied in 10 body builders using anabolic steroids and 14 body builders who did not use steroids (control subjects). All subjects underwent noninvasive 24-hour blood pressure monitoring, ...

journal_title：Journal of clinical pharmacology

authors： Palatini P,Giada F,Garavelli G,Sinisi F,Mario L,Michieletto M,Baldo-Enzi G

更新日期：1996-12-01 00:00:00

abstract：:To assess the effect of orlistat on the pharmacokinetics and pharmacodynamics of warfarin, a third-party blind, placebo-controlled, randomized, two-way crossover study was performed in 12 healthy volunteers. Each participant received single 30-mg oral doses of racemic warfarin sodium (Coumadin; DuPont Pharma, Wilmingt...

journal_title：Journal of clinical pharmacology

authors： Zhi J,Melia AT,Guerciolini R,Koss-Twardy SG,Passe SM,Rakhit A,Sadowski JA

更新日期：1996-07-01 00:00:00

abstract：:Twenty healthy volunteers (age ranging from 19 to 72) were studied for their aldosterone response to oral administration of 10 mg cisapride, a serotonin-4 receptor agonist. The participants were studied after minimum of 4-hour ambulation (high basal renin) and a repeated test after overnight bed rest (low basal renin)...

journal_title：Journal of clinical pharmacology

authors： Huang YY,Hsu BR,Tsai JS

更新日期：1997-12-01 00:00:00

abstract：:Acute asthma exacerbations are primarily due to airway inflammation and remain one of the most frequent reasons for childhood hospitalizations. Although systemic corticosteroids remain the mainstay of therapy because of their anti-inflammatory properties, not all inflammatory pathways are responsive to systemic cortic...

journal_title：Journal of clinical pharmacology

authors： Arnold DH,Van Driest SL,Reiss TF,King JC,Akers WS

更新日期：2021-03-01 00:00:00

abstract：:Everolimus is an immunosuppressant intended for use with cyclosporine in acute-rejection prophylaxis following organ transplantation. The possibility of a drug interaction of cyclosporine on everolimus was assessed. In this randomized, two-period, crossover study, 24 healthy subjects received a single oral dose of 2 m...

journal_title：Journal of clinical pharmacology

authors： Kovarik JM,Kalbag J,Figueiredo J,Rouilly M,Frazier OL,Rordorf C

更新日期：2002-01-01 00:00:00

abstract：:A novel, nonscrotal, transdermal delivery system for testosterone therapy has been marketed for treatment of hypogonadal men. The usual dose of this system is two 2.5 mg/day systems applied daily. A new system has been developed that administers a dose of 5 mg/day using a single patch rather than two patches. A random...

journal_title：Journal of clinical pharmacology

authors： Wilson DE,Meikle AW,Boike SC,Fairless AJ,Etheredge RC,Jorkasky DK

更新日期：1998-01-01 00:00:00

abstract：:Pentoxifylline, a nonselective phosphodiesterase inhibitor, has immunomodulatory activity in vitro and in vivo and potentiates the suppressive effects of glucocorticoids and cyclosporine on lymphocyte proliferation in vitro. Since phosphodiesterase isotypes 3 and 4 predominate in lymphocytes, the authors measured the ...

journal_title：Journal of clinical pharmacology

authors： Briggs WA,Wu Q,Orgul O,Choi M,Scheel PJ Jr,Burdick J

更新日期：1999-08-01 00:00:00

abstract：:The relationship between indenolol (an investigational agent) plasma levels and the drug's effect on blood pressure and heart rate was investigated after single and repeated once daily administration at two dosage levels (60 mg and 120 mg) in two different groups of patients with first or second stage hypertension, ac...

journal_title：Journal of clinical pharmacology

authors： Sega R,Mailland F,Colombo F,Groothold G,Pantarotto C,Guenzati G,Libretti A

更新日期：1985-07-01 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