Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment.

abstract：:Droxicam is a nonsteroidal anti-inflammatory drug that is a pro-drug of piroxicam. The influence of concomitant administration of antacid or ranitidine on droxicam pharmacokinetics has been investigated. On three separate phases, 15 healthy volunteers received a single oral 20-mg dose of droxicam either alone, with an...

journal_title：Journal of clinical pharmacology

authors： Bartlett A,Costa A,Martínez L,Roser R,Sagarra R,Sánchez J

更新日期：1992-12-01 00:00:00

abstract：:The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), the German drug regulation authority, issued guidelines for determining whether bioavailability/bioequivalence studies are required for certain drugs. This decision tree is based on pharmacodynamic, pharmacokinetic, and physicochemical criteria. Details ...

journal_title：Journal of clinical pharmacology

authors： Gleiter CH,Klotz U,Kuhlmann J,Blume H,Stanislaus F,Harder S,Paulus H,Poethko-Müller C,Holz-Slomczyk M

更新日期：1998-10-01 00:00:00

abstract：:Sirolimus (RAPA) and cyclosporine (CsA) are immunosuppressive compounds that are being used concomitantly in renal transplant patients. Both drugs are dosed orally, have common intestinal and hepatic metabolism and intestinal transport mechanisms, and thus offer potential for pharmacokinetic drug interactions. A singl...

journal_title：Journal of clinical pharmacology

authors： Zimmerman JJ,Harper D,Getsy J,Jusko WJ

更新日期：2003-10-01 00:00:00

abstract：:There has been a considerable revolution in the field of hypertension therapy. We have gone through an era in which patients with severe hypertension and those with accelerated hypertension had a very short life expectancy. Currently blood pressure can be readily controlled with a marked improvement in longevity. We h...

journal_title：Journal of clinical pharmacology

authors： Somberg J,Ehrenpreis S,Shroff G,Khosla S

更新日期：1993-03-01 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：:To determine if ordinary doses of nitrates produce a significant increase in methemoglobin, methemoglobin levels were measured in 59 randomly selected patients with coronary artery disease and unstable angina pectoris who were receiving organic nitrate therapy. Patients were taking isosorbide dinitrate, 2% nitroglycer...

journal_title：Journal of clinical pharmacology

authors： Arsura E,Lichstein E,Guadagnino V,Nicchi V,Sanders M,Hollander G,Greengart A

更新日期：1984-04-01 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：:An open-label, randomized, crossover study was performed in healthy male volunteers to evaluate the potential pharmacokinetic and pharmacodynamic interactions and tolerability of single oral doses of modafinil (200 mg) and dextroamphetamine (10 mg). Blood samples were collected for determination of plasma levels of mo...

journal_title：Journal of clinical pharmacology

authors： Wong YN,Wang L,Hartman L,Simcoe D,Chen Y,Laughton W,Eldon R,Markland C,Grebow P

更新日期：1998-10-01 00:00:00

abstract：:Guidelines have been developed by the Bureau of Drugs, FDA, for antinflammatory drug development. They address the problem of efficacy and safety testing but leave the definition of qualified investigators and appropriate subjects unstated. The natural history of rheumatoid arthritis, the most-studied chronic inflamma...

journal_title：Journal of clinical pharmacology

authors： Ehrlich GE

更新日期：1977-11-01 00:00:00

abstract：:Clinical pharmacology of L-asparaginase was compared by intramuscular and intravenous injections in 12 patients with metastatic cancer or leukemia. Following a single intramuscular injection at the gluteal site of L-asparaginase (10,000 IU/m2), the enzyme appeared in plasma as measured initially at 1 hour, but plateau...

journal_title：Journal of clinical pharmacology

authors： Ho DH,Yap HY,Brown N,Benjamin RS,Friereich EJ,Blumenschein GR,Bodey GP

更新日期：1981-02-01 00:00:00

abstract：:The frequency of hemodialysis-associated hemorrhage was studied prospectively in two successive, parallel, heparin-controlled studies using epoprostenol (PGI2; average dose, 4.1 ng/kg.min) as the sole antithrombotic agent. Sixty-three patients with active or recently active bleeding underwent 163 hemodialysis treatmen...

journal_title：Journal of clinical pharmacology

authors： Swartz RD,Flamenbaum W,Dubrow A,Hall JC,Crow JW,Cato A

更新日期：1988-09-01 00:00:00

abstract：:Assessment of drug-induced venodilation by the dorsal hand vein compliance method requires stable constriction of the vein. This study was designed to investigate intra- and intersubject reproducibility of the venous preconstriction technique in response to phenylephrine and prostaglandin F2 alpha and to determine the...

journal_title：Journal of clinical pharmacology

authors： Schindler C,Grossmann M,Dobrev D,Francke K,Ravens U,Kirch W

更新日期：2003-03-01 00:00:00

abstract：:Few treatments for human diseases have received as much investigation in the past 20 years as probiotics. In 2017, English-language meta-analyses totaling 52 studies determined the effect of probiotics on conditions ranging from necrotizing enterocolitis and colic in infants to constipation, irritable bowel syndrome, ...

journal_title：Journal of clinical pharmacology

authors： Liu Y,Tran DQ,Rhoads JM

更新日期：2018-10-01 00:00:00

abstract：:Procaterol, a new beta-adrenergic agonist, was tested in two different doses in patients with reversible airway obstruction. Single oral doses of 0.05 or 0.1 mg produce an increase in measured expiratory flow rates, and the peak and duration of action are both dose related. Side effects reported during this one-day st...

journal_title：Journal of clinical pharmacology

authors： Zanetti CL,Rotman HH,Dresner AJ

更新日期：1982-05-01 00:00:00

abstract：:Cannabichromene (CBC) is one of four major cannabinoids in Cannabis sativa L. and is the second most abundant cannabinoid in drug-type cannabis. Cannabichromene and some of its homologs, analogs, and isomers were evaluated for antiinflammatory, antibacterial, and antifungal activity. Antiinflammatory activity was eval...

journal_title：Journal of clinical pharmacology

authors： Turner CE,Elsohly MA

更新日期：1981-08-01 00:00:00

abstract：:Repaglinide is a novel insulin secretagogue developed in response to the need for a fast-acting, oral prandial glucose regulator for the treatment of type 2 (non-insulin-dependent) diabetes mellitus. Repaglinide is metabolized mainly in the liver; its pharmacokinetics may therefore be altered by hepatic dysfunction. T...

journal_title：Journal of clinical pharmacology

authors： Hatorp V,Walther KH,Christensen MS,Haug-Pihale G

更新日期：2000-02-01 00:00:00

abstract：:The medium-term (16 weeks) effects of the combination of captopril and hydrochlorothiazide (HCTZ) on some metabolic indexes, particularly on plasma lipoproteins, were evaluated in 20 mild to moderate hypertensive outpatients. After a 4-week wash-out period, the subjects were given one tablet of a new commercially avai...

journal_title：Journal of clinical pharmacology

authors： Perani G,Martignoni A,Muggia C,Ferrari T,Simonich P,Pompei R,Marchesi E,Finardi G

更新日期：1990-11-01 00:00:00

abstract：:CGS 13080, a selective thromboxane synthetase inhibitor, was given intravenously (0.6 mg/kg over 6 hours) to eight hypertensive (diastolic 95-115 mm Hg) euvolemic caucasian females on their customary salt intake (24 hour urine Na: 142.9 +/- 14.8 meq). No change occurred in blood pressure or glomerular filtration rate ...

journal_title：Journal of clinical pharmacology

authors： Weir MR,Klassen DK,Hoover N,Douglas FL

更新日期：1989-12-01 00:00:00

abstract：:BIA 10-2474 (a fatty acid amide hydrolase inhibitor) was evaluated in a first-in-human phase 1 study in normal volunteers to assess safety/tolerability, pharmacokinetics, pharmacodynamics, and food effect. The dose-escalation process consisted of a single-ascending-dose phase (SAD) and multiple-ascending-dose phase (M...

journal_title：Journal of clinical pharmacology

authors： Chaikin P

更新日期：2017-06-01 00:00:00

abstract：:Cefprozil, a new broad-spectrum oral cephalosporin, is composed of cis and trans isomers in an approximate 90:10 ratio. The pharmacokinetics of a single oral 1000-mg dose of cefprozil were evaluated in 6 healthy subjects and 24 patients with various degrees of renal impairment. Six of these subjects were studied both ...

journal_title：Journal of clinical pharmacology

authors： Shyu WC,Pittman KA,Wilber RB,Matzke GR,Barbhaiya RH

更新日期：1991-04-01 00:00:00

abstract：:This trial was conducted to evaluate the pharmacokinetics and safety of a sodium oxybate (gamma-hydroxybutyrate [GHB]) oral solution in narcoleptic patients after acute and chronic treatment. An open-label, two-period, two-treatment study design was used. Trial subjects included 13 patients with polysomnographically c...

journal_title：Journal of clinical pharmacology

authors： Borgen LA,Okerholm RA,Lai A,Scharf MB

更新日期：2004-03-01 00:00:00

abstract：:The efficacy and safety of esmolol, a titratable intravenous beta-adrenergic blocking agent with a short elimination half-life (t 1/2 = 9.0 min) was evaluated in a multicenter open-label study for the treatment of supraventricular tachyarrhythmias (heart rate greater than 100 bpm). The study also investigated the feas...

journal_title：Journal of clinical pharmacology

authors： Das G,Tschida V,Gray R,Dhurandhar R,Lester R,McGrew F,Askenazi J,Kaplan K,Emanuele M,Turlapaty P

更新日期：1988-08-01 00:00:00

abstract：:Steady state pharmacokinetics, absolute bioavailability, and dose proportionality of cefepime were evaluated in healthy male subjects after single (250, 500, 1000, or 2000 mg) and multiple (1000 mg every 12 hours for 10 days) intramuscular injections. Safety and tolerance were also monitored. High performance liquid c...

journal_title：Journal of clinical pharmacology

authors： Barbhaiya RH,Knupp CA,Tenney J,Martin RR,Weidler DJ,Pittman KA

更新日期：1990-10-01 00:00:00

abstract：:Unresolved issues of ethical, methodological, and legal concerns in the use of normal healthy volunteers persist. Financial incentives in their recruitment offer a unique ethical dilemma because of questions surrounding payment. A review of literature was conducted to obtain research systematically examining volunteer...

journal_title：Journal of clinical pharmacology

authors： Tishler CL,Bartholomae S

更新日期：2002-04-01 00:00:00

abstract：:Nine patients 55 to 74 years old with Parkinson's disease were tested before and after treatment with 50 to 225 mg dimepramine fumarate (CIBA G-31406) for about three weeks daily in order to determine the drug's effects on electrodermal responsiveness to a series of unpredictably occurring loud sounds. Twelve control ...

journal_title：Journal of clinical pharmacology

authors： Oscar-Berman M,Gade A,Feldman RG,Saavedra MA

更新日期：1979-10-01 00:00:00

abstract：:This multi-center, randomized, double-blind, multiple dose-escalation study was conducted to assess the pharmacokinetics and pharmacodynamics of a newly developed polyethylene glycol (PEG)-conjugated glucagon-like peptide-1 (GLP-1) receptor agonist, PEX168 once weekly in Chinese patients with type 2 diabetes (T2DM). F...

journal_title：Journal of clinical pharmacology

authors： Yang GR,Zhao XL,Jin F,Shi LH,Yang JK

更新日期：2015-02-01 00:00:00

abstract：:Steady-state inhibitory activity of rofecoxib (Vioxx) on COX-2 versus COX-1 was compared with that of commonly used nonsteroidal anti-inflammatory drugs (NSAIDs) in 76 healthy volunteers randomized to placebo, rofecoxib 12.5 mg qd, rofecoxib 25 mg qd, diclofenac 50 mg tid, ibuprofen 800 mg tid, sodium naproxen 550 mg ...

journal_title：Journal of clinical pharmacology

authors： Van Hecken A,Schwartz JI,Depré M,De Lepeleire I,Dallob A,Tanaka W,Wynants K,Buntinx A,Arnout J,Wong PH,Ebel DL,Gertz BJ,De Schepper PJ

更新日期：2000-10-01 00:00:00

abstract：:The new antidepressant nomifensin (Hoechst 36984), a drug which showed less cardiotoxicity than tricyclics, was compared in a single-blind comparative trial with viloxazine. Forty elderly depressed patients were treated during four weeks. Nomifensin, N=21, 75 mg/day; viloxazine, N=19, 150 mg/day). Antidepressant effec...

journal_title：Journal of clinical pharmacology

authors： Moizeszowicz J,Subirá S

更新日期：1977-01-01 00:00:00

abstract：:Two phase I open-label studies were conducted to investigate the pharmacokinetics (PK), safety, and tolerability of single oral doses of selumetinib in subjects with end-stage renal disease (ESRD) undergoing hemodialysis and subjects with varying degrees of hepatic impairment; both studies included a matched control g...

journal_title：Journal of clinical pharmacology

authors： Dymond AW,Martin P,So K,Huang Y,Severin P,Holmes V,Mariani G,Marbury T

更新日期：2017-05-01 00:00:00

abstract：:This study was performed to estimate the population pharmacokinetic (PK) parameters of etanercept in pediatric juvenile rheumatoid arthritis (JRA) patients and to compare the steady-state time-concentration profiles between etanercept 0.8-mg/kg once-weekly and 0.4-mg/kg twice-weekly subcutaneous (SC) regimens by clini...

journal_title：Journal of clinical pharmacology

authors： Yim DS,Zhou H,Buckwalter M,Nestorov I,Peck CC,Lee H

更新日期：2005-03-01 00:00:00