Phase 1 First-in-Human, Single- and Multiple-Ascending Dose, and Food Effect Studies to Assess the Safety, Tolerability, and Pharmacokinetics of Presatovir for the Treatment of Respiratory Syncytial Virus Infection.

abstract：:A clinical study of bumetanide, a new diuretic, was conducted in outpatients of a cardiology clinic to determine its long-term effectiveness and safety in the treatment of peripheral edema due to congestive heart failure. The drug was administered for at least 24 weeks on a selected group of 34 patients. The patients ...

journal_title：Journal of clinical pharmacology

authors： Handler B,Dhingra RC,Rosen KM

更新日期：1981-11-01 00:00:00

abstract：:The principal causes of digitalis toxicity are overdose, reduced volume of distribution, reduced renal elimination, and increased myocardial sensitivity. The metabolic mechanism of digitalis toxicity is intense inhibition of sarcolemma Na-K ATPase, which leads to increases of intracellular Na+ and Ca2+ and arrhythmoge...

journal_title：Journal of clinical pharmacology

authors： Bigger JT Jr

更新日期：1985-10-01 00:00:00

abstract：:Twenty young (45 years or younger) and 20 older (55 years or older) adult patients with mild hypertension were enrolled in this study to compare the hemodynamic effects of labetalol versus placebo in two age groups. Ten patients in each group were randomly assigned to receive either a single oral dose of labetalol (20...

journal_title：Journal of clinical pharmacology

authors： Buell JC,Eliot RS,Plachetka JR,Little MR

更新日期：1988-04-01 00:00:00

abstract：:Despite a paucity of data, the role of intravenous lidocaine (IVLI) as adjunctive analgesia in the intensive care unit (ICU) seems promising due to a low potential to contribute to respiratory depression. A retrospective chart review was conducted to evaluate the safety and effectiveness of IVLI for the treatment of p...

journal_title：Journal of clinical pharmacology

authors： Mo Y,Thomas MC,Antigua AD,Ebied AM,Karras GE Jr

更新日期：2017-07-01 00:00:00

abstract：:The hypotensive effect, kinetics, and concentration-response relationship of labetalol, alpha beta- and alpha 1-adrenoceptor blocking drug, were studied in seven women with a moderate-to-severe hypertension (averaged diastolic blood pressure [DBP] of 100 to 120 mm Hg measured during a 1- to 2-day hospitalization perio...

journal_title：Journal of clinical pharmacology

authors： Saotome T,Minoura S,Terashi K,Sato T,Echizen H,Ishizaki T

更新日期：1993-10-01 00:00:00

abstract：:The effect of lovastatin given before percutaneous coronary angioplasty (PTCA) on early restenosis was investigated in men with mild to moderate hypercholesterolemia. Thirty-four hypercholesterolemic patients (serum LDL cholesterol 130-200 mg/dL) undergoing their first PTCA completed a 6-month prospective, double-blin...

journal_title：Journal of clinical pharmacology

authors： Beigel Y,Zafrir N,Teplitzky Y,Neuman Y,Gavish D,Wurzel M,Fainaru M

更新日期：1995-06-01 00:00:00

abstract：:Gestational diabetes mellitus (GDM) has affected a great number of pregnant women worldwide. Artemisia extracts have been found to exhibit a potent antidiabetic effect in the treatment of type 2 diabetes mellitus. We aimed to examine the effects of Artemisia extract on insulin resistance and lipid profiles in pregnant...

journal_title：Journal of clinical pharmacology

authors： Sun X,Sun H,Zhang J,Ji X

更新日期：2016-12-01 00:00:00

abstract：:The pharmacokinetics, pharmacodynamics, and safety of the marketed formulation of microencapsulated octreotide acetate were evaluated in an open-label study in 22 healthy cholecystectomized subjects. Each subject received a single 30 mg dose of microencapsulated octreotide acetate intramuscularly (i.m.). Concentration...

journal_title：Journal of clinical pharmacology

authors： Chen T,Miller TF,Prasad P,Lee J,Krauss J,Miscik K,Kalafsky G,McLeod JF

更新日期：2000-05-01 00:00:00

abstract：:In most Wuchereria bancrofti and Brugia malayi infections, the microfilaria are found in the blood in greatest number between 10 p.m. and 2 a.m., indicating that chronotherapy may be beneficial in treating such infections. This study reports the influence of time of administration on the pharmacokinetics of diethylcar...

journal_title：Journal of clinical pharmacology

authors： Bolla S,Boinpally RR,Poondru S,Devaraj R,Jasti BR

更新日期：2002-03-01 00:00:00

abstract：:The aim of this study was to investigate if the concomitant administration of the positive inotropic drug enoximone (100 mg tid) has any effect on the morning through levels of the cardiac glycoside digoxin in 17 patients with congestive heart failure (NYHA II-IV). Plasma concentrations of digoxin were 1.05 +/- 0.37 n...

journal_title：Journal of clinical pharmacology

authors： Trenk D,Hertrich F,Winkelmann B,Glauner T,Dieterich HA,Jähnchen E

更新日期：1990-03-01 00:00:00

abstract：:Propafenone and its 5-hydroxy metabolite exhibit different electrophysiological properties. Objectives of the CAQ-PAF study were (1) to develop a strategy favoring propafenone instead of 5-hydroxypropafenone in plasma following oral administration of propafenone and (2) to evaluate the potential of low-dose quinidine ...

journal_title：Journal of clinical pharmacology

authors： O'Hara GE,Philippon F,Gilbert M,Champagne J,Michaud V,Charbonneau L,Pruneau G,Hamelin BA,Geelen P,Turgeon J

更新日期：2012-02-01 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：:A physiologically based pharmacokinetic model (PBPK) was built for citalopram using Simcyp-based absorption, distribution, metabolism, and excretion simulator. Various physicochemical properties of citalopram were obtained from the published literature. The in vitro-in vivo extrapolation method was used to predict cle...

journal_title：Journal of clinical pharmacology

authors： Wu X,Zhang H,Miah MK,Caritis SN,Venkataramanan R

更新日期：2020-04-01 00:00:00

abstract：:PRX-00023 is a novel, nonazapirone 5-HT1A agonist in clinical development for treatment of affective disorders. The objectives of the initial clinical phase I studies (a single ascending dose study and multiple dose-ascending and high-dose titration studies) were to measure the pharmacokinetics, pharmacodynamic (neuro...

journal_title：Journal of clinical pharmacology

authors： Iyer GR,Reinhard JF Jr,Oshana S,Kauffman M,Donahue S

更新日期：2007-07-01 00:00:00

abstract：:The integrated glucose-insulin (IGI) model is a previously published semimechanistic model that describes plasma glucose and insulin concentrations after glucose challenges. The aim of this work was to use knowledge of physiology to improve the IGI model's description of glucose absorption and gastric emptying after t...

journal_title：Journal of clinical pharmacology

authors： Alskär O,Bagger JI,Røge RM,Knop FK,Karlsson MO,Vilsbøll T,Kjellsson MC

更新日期：2016-03-01 00:00:00

abstract：:The antihypertensive effect and safety of hydrochlorothiazide administration as a single drug and together with medroxalol were determined in 20 patients with primary hypertension. Following two biweekly intervals on placebo and hydrochlorothiazide, medroxalol was started at 100 mg three times a day and titrated again...

journal_title：Journal of clinical pharmacology

authors： Vlachakis ND,Valasquez M,Alexander N,Maronde RF

更新日期：1983-10-01 00:00:00

abstract：:Beverage-drug interactions have remained an active area of research and have been the subject of extensive investigations in the past 2 decades. The known mechanisms of clinically relevant beverage-drug interactions include modulation of the activity of cytochrome P450 (CYP) 3A and organic anion-transporting polypepti...

journal_title：Journal of clinical pharmacology

authors： An G,Mukker JK,Derendorf H,Frye RF

更新日期：2015-12-01 00:00:00

abstract：:Antinociception by nonsteroidal antiinflammatory drugs, notably diclofenac and S(+)-ibuprofen, has traditionally been attributed to peripheral tissue cyclooxygenase inhibition. This study investigates the potential role of the nitric oxide system for the central antinociceptive effects of diclofenac, S(+)-, and R(-)-i...

journal_title：Journal of clinical pharmacology

authors： Björkman R,Hallman KM,Hedner J,Hedner T,Henning M

更新日期：1996-12-01 00:00:00

abstract：:The primary objective of this study was to identify intravenous regimens of tipifarnib that would mimic the systemic exposure obtained after the current twice-daily oral administration of tipifarnib. After determination of an intravenous dose that 6 subjects with advanced cancer could tolerate, another 26 subjects wer...

journal_title：Journal of clinical pharmacology

authors： Zhang S,Zannikos P,Awada A,Piccart-Gebhart M,Dirix LY,Fumoleau P,Verhaeghe T,Francois M,De Porre P

更新日期：2006-10-01 00:00:00

abstract：:Udenafil, a cyclic guanosine monophosphate-specific phosphodiesterase type 5 inhibitor, has been developed to treat erectile dysfunction. We evaluated the effect of age on the pharmacokinetics and tolerability of udenafil. A single-center, open-label, parallel-group phase 1 study was conducted in healthy adult subject...

journal_title：Journal of clinical pharmacology

authors： Choi HK,Jung JA,Shon J,Bahng MY,Cho DY,Yeo CW,Kim EY,Shin JG

更新日期：2016-11-01 00:00:00

abstract：:The effect of hepatic impairment on the pharmacokinetics of a sustained-release formulation of ranolazine and 3 major metabolites was investigated in an open-label, parallel-group study. Ranolazine (875-mg loading dose followed by 500 mg every 12 hours for a total of 4 maintenance doses) was administered to subjects w...

journal_title：Journal of clinical pharmacology

authors： Abdallah H,Jerling M

更新日期：2005-07-01 00:00:00

abstract：:This study outlines the attempts of four states (Louisiana, Kansas, Wisconsin, and Michigan) to restrict anorectic prescriptions. The actions in these four states exemplify the various mechanisms used in regulating anorectics, ranging from educational efforts to legislative enactments. We examine the evidence used in ...

journal_title：Journal of clinical pharmacology

authors： Richard BW,Lasagna L

更新日期：1988-05-01 00:00:00

abstract：:CS-0777 is a selective sphingosine 1-phosphate receptor-1 (S1P(1)) modulator under development for treatment of autoimmune conditions. A randomized, double-blind, placebo-controlled study was conducted to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of CS-0777 in escalat...

journal_title：Journal of clinical pharmacology

authors： Moberly JB,Rohatagi S,Zahir H,Hsu C,Noveck RJ,Truitt KE

更新日期：2012-07-01 00:00:00

abstract：:To compare the steady-state kinetic profiles and ectopy-suppression rates of two sustained-release forms of quinidine with those of a conventional quinidine preparation, 18 patients with ventricular ectopy were studied in randomized crossover fashion. The drugs were conventional quinidine sulfate 300 mg q6h, sustained...

journal_title：Journal of clinical pharmacology

authors： Lehmann CR,Boran KJ,Kruyer WB,Van Reet RE,Scoville GS,Pierson WP,Melikian AP,Crowe JT,Wright GJ

更新日期：1986-11-01 00:00:00

abstract：:TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d7 ] acetate hydrochloride) is a novel selective noradrenaline reuptake inhibitor being developed for the treatment of stress urinary incontinence. An in vitro study and a physiologically based pharmacokinetic model simulation showed that TAS-303 had inhibit...

journal_title：Journal of clinical pharmacology

authors： Kumagai Y,Fujita T,Maeda M,Sasaki Y,Nagaoka M,Huang J,Takenaka T,Kawai M

更新日期：2020-06-01 00:00:00

abstract：:The onset and offset of the electropharmacologic effect of procainamide was studied in nine patients with ventricular arrhythmias. Procainamide was given at a constant infusion rate of 0.27 +/- 0.05 mg/kg/min for 50 to 60 minutes to an average total dose of 15.5 +/- 4.4 mg/kg. The QRS interval (used as an index of ele...

journal_title：Journal of clinical pharmacology

authors： Liem LB,Yee YG,Swerdlow CD,Kates RE

更新日期：1988-11-01 00:00:00

abstract：:We report population pharmacokinetic, pharmacodynamic, and pharmacokinetic-safety analyses to support phase II/III dose/regimen selection of alisertib, a selective Aurora A kinase (AAK) inhibitor. Phase I studies in adult cancer patients evaluated dosing on Days 1-7 in 21-day cycles or Days 1-21 in 35-day cycles, with...

journal_title：Journal of clinical pharmacology

authors： Venkatakrishnan K,Zhou X,Ecsedy J,Mould DR,Liu H,Danaee H,Fingert H,Kleinfield R,Milton A

更新日期：2015-03-01 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：:Long-term prolactin excess is often accompanied by numerous metabolic complications. No previous study has compared the effect of statin therapy on circulating levels of cardiometabolic risk factors in patients with elevated and normal prolactin levels. The study population consisted of 3 age-, weight-, and lipid-matc...

journal_title：Journal of clinical pharmacology

authors： Krysiak R,Szkróbka W,Okopień B

更新日期：2019-01-01 00:00:00

abstract：:Validation of study methods is a prerequisite for their usability. Empirical quality criteria based on test-theoretical principles are useful for this purpose. These criteria are discussed for several noninvasive methods used in cardiovascular clinical pharmacology: electrocardiography, systolic time intervals, blood ...

journal_title：Journal of clinical pharmacology

authors： de Mey C,Erb KA

更新日期：1997-01-01 00:00:00