Model-based analysis of covariate effects on population pharmacokinetics of thrombomodulin alfa in patients with disseminated intravascular coagulation and normal subjects.

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：:The effect of epoprostenol on the pharmacokinetics of furosemide was investigated in 23 patients with end-stage congestive heart failure (CHF) receiving conventional therapy alone or conventional therapy plus epoprostenol. Estimates of the apparent oral clearance, volume of distribution, and absorption rate constant f...

journal_title：Journal of clinical pharmacology

authors： Carlton LD,Patterson JH,Mattson CN,Schmith VD

更新日期：1996-03-01 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：:Eight healthy men received 100 mg oral doses of etretinate separated by two-week washout periods in an open, randomized, crossover study. Etretinate was administered during a complete fast, with a standard high fat breakfast, a standard high carbohydrate breakfast, and 16 ounces of whole milk. Plasma samples were obta...

journal_title：Journal of clinical pharmacology

authors： Colburn WA,Gibson DM,Rodriguez LC,Buggé CJ,Blumenthal HP

更新日期：1985-11-01 00:00:00

abstract：:A double-blind, placebo-controlled trial was performed to establish the duration of action of antihistamines and their ability to attenuate the adverse affects associated with histamine release. Thirty volunteers were assigned randomly to receive either placebo or a combination of the H1 blocker dimetindene maleate (0...

journal_title：Journal of clinical pharmacology

authors： Doenicke A,Moss J,Toledano A,Hoernecke R,Lorenz W,Ostwald P

更新日期：1997-02-01 00:00:00

abstract：:While sulindac failed to affect significantly warfarin-induced hypoprothrombinemia in normal male volunteers, it markedly prolonged prothrombin time in a patient with a renal tubular defect who had been anticoagulated with warfarin. This difference in individual response with respect to a drug interaction illustrates ...

journal_title：Journal of clinical pharmacology

authors： Loftin JP,Vesell ES

更新日期：1979-11-01 00:00:00

abstract：:Sixteen healthy volunteers were given either oral or intravenous doses of aminophylline (125 mg) at 9:00 A.M. and 9:00 P.M. under controlled food conditions. Measured at regular time intervals by homogeneous enzyme immunoassay, the plasma theophylline concentrations 1.5 and 2 hours after oral aminophylline were signif...

journal_title：Journal of clinical pharmacology

authors： Watanabe H,Nakano S,Nagai K,Ogawa N

更新日期：1984-11-01 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 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：:This experiment represents the first time that it has been possible to measure a body fluid compartment by direct means during spaceflight. Based on the results observed in the five crewmen in this study, it is concluded that TBW decreases by 3.4% after 1 to 3 days of exposure to microgravity in the Space Shuttle. Som...

journal_title：Journal of clinical pharmacology

authors： Leach CS,Inners LD,Charles JB

更新日期：1991-10-01 00:00:00

abstract：:Because of the key role blood viscosity plays in the regulation of blood pressure (BP) and the hemorheological effects of pentoxifylline (PTX), this study was conducted to evaluate whether PTX can reduce BP when added to captopril in patients with stage 1 hypertension. In this randomized clinical trial 62 patients wit...

journal_title：Journal of clinical pharmacology

authors： Namdar H,Khani E,Pourrashid MH,Entezari-Maleki T

更新日期：2020-02-01 00:00:00

abstract：:The anxiolytic triazolobenzodiazepine alprazolam was administered to six male patients, aged 26 to 46 years, with panic disorder or agoraphobia (with panic attacks) to assess clinical effects and steady-state pharmacokinetics following multiple dosing at three levels: 3.0 mg/d, 6.0 mg/d, and 9.0 mg/d. Multiple-dose ki...

journal_title：Journal of clinical pharmacology

authors： Ciraulo DA,Barnhill JG,Boxenbaum HG,Greenblatt DJ,Smith RB

更新日期：1986-04-01 00:00:00

abstract：:Respiratory syncytial virus (RSV)-associated respiratory tract infection is a leading cause of hospitalizations in infants for which no effective treatment exists. RSV infection is also an important cause of respiratory disease in adults and immunocompromised patients. Presatovir (GS-5806) is an orally bioavailable an...

journal_title：Journal of clinical pharmacology

authors： German P,Xin Y,Chien JW,Weng W,Mackman R,Lewis SA,Meng A,Ling J,Mathias A

更新日期：2018-08-01 00:00:00

abstract：:A clinical study was performed on 41 asthmatic patients. After complete physical and spirometric examinations, they received capsules containing 200 mg anhydrous theophylline per capsule t.i.d. for three weeks. All other antiasthmatic medications were omitted during this study. The results showed that these capsules (...

journal_title：Journal of clinical pharmacology

authors： Miller J,Salem H

更新日期：1976-07-01 00:00:00

abstract：:Many drugs have incomplete systemic availability after oral dosage. This can be attributed to incomplete absorption from the gastrointestinal tract, or to presystemic extraction, in which a fraction of an orally administered dose is biotransformed before reaching the systemic circulation. Presystemic extraction can oc...

journal_title：Journal of clinical pharmacology

authors： Greenblatt DJ

更新日期：1993-07-01 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：:The effects of propafenone on the pharmacokinetics and pharmacodynamics of propranolol were evaluated in 12 healthy male subjects. Both propafenone and propranolol were each administered alone for one week followed by concomitant administration for an additional week. Blood samples, obtained at steady-state, were anal...

journal_title：Journal of clinical pharmacology

authors： Kowey PR,Kirsten EB,Fu CH,Mason WD

更新日期：1989-06-01 00:00:00

abstract：:The pharmacokinetics and safety of a single oral dose of 200-mg plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD) in oral solution (Epidiolex in the United States; 100 mg/mL) were assessed in subjects with mild to severe hepatic impairment (n =  8 each for mild and moderate, n = 6 for sever...

journal_title：Journal of clinical pharmacology

authors： Taylor L,Crockett J,Tayo B,Morrison G

更新日期：2019-08-01 00:00:00

abstract：:Aprepitant, a neurokinin antagonist, is an effective antiemetic agent in chemotherapy for delayed nausea and vomiting. The study objective was to evaluate the pharmacokinetics of aprepitant and concurrent cyclophosphamide (CY), often a component of hematopoietic stem cell transplant (HSCT) conditioning regimen, in can...

journal_title：Journal of clinical pharmacology

authors： Bubalo JS,Cherala G,McCune JS,Munar MY,Tse S,Maziarz R

更新日期：2012-04-01 00:00:00

abstract：:The efficacy and tolerability of aminoglutethimide for the treatment of Cushing's syndrome was assessed in 66 cases three of which are described in the present paper. Aminoglutethimide provided palliation from the signs and symptoms of hypercorticism in 13 of 21 patients with metastatic adrenocortical carcinoma and fo...

journal_title：Journal of clinical pharmacology

authors： Misbin RI,Canary J,Willard D

更新日期：1976-11-01 00:00:00

abstract：:A randomized, dose-escalating study evaluated the pharmacokinetics of single and multiple oral doses of pirfenidone, a promising antifibrotic agent, in 48 healthy Chinese volunteers. The effects of sex and food on the pharmacokinetics of pirfenidone were also evaluated. Pharmacokinetics was determined from serial bloo...

journal_title：Journal of clinical pharmacology

authors： Shi S,Wu J,Chen H,Chen H,Wu J,Zeng F

更新日期：2007-10-01 00:00:00

abstract：:The safety and efficacy of intravenous (i.v.) torsemide as adjunctive therapy for acute cardiogenic pulmonary edema was evaluated. Thirteen patients were treated with i.v. torsemide and six patients, with i.v. furosemide, as a positive control. Doses of torsemide, 20 mg or 40 mg, and furosemide, 40 mg or 80 mg, were a...

journal_title：Journal of clinical pharmacology

authors： Stringer KA,Watson W,Gratton M,Wolfe R

更新日期：1994-11-01 00:00:00

abstract：:Many biologically active synthetic drugs contain chiral centers, although they are used as racemic mixtures. Enantiomers are hard to distinguish in the chemical laboratory but are readily discriminated in the body and differ in their biological activities and disposition. The pharmacokinetic profiles of enantiomers ca...

journal_title：Journal of clinical pharmacology

authors： Caldwell J

更新日期：1992-10-01 00:00:00

abstract：:Isosorbide dinitrate is one of the most commonly prescribed medications for the treatment of ischemic heart disease. It has been demonstrated to be ineffective relative to placebo when taken inappropriately. This study objectively documents the magnitude and nature of compliance in 68 ambulatory patients who were pres...

journal_title：Journal of clinical pharmacology

authors： Straka RJ,Fish JT,Benson SR,Suh JT

更新日期：1996-07-01 00:00:00

abstract：:Atorvastatin is a common option among the HMG-CoA reductase inhibitors for the treatment of lipid disorders because of its excellent lipid-lowering efficacy and overall safety profile. Although these agents can rarely cause rhabdomyolysis by themselves, macrolides, among other agents, have been demonstrated to increas...

journal_title：Journal of clinical pharmacology

authors： Amsden GW,Kuye O,Wei GC

更新日期：2002-04-01 00:00:00

abstract：:Mavrilimumab is a fully human monoclonal antibody that binds to granulocyte-macrophage colony stimulating factor receptor α (GM-CSFRα) with high affinity and specificity and has potential application in various inflammatory diseases. The objective of this investigation was to develop a mechanistic population model to ...

journal_title：Journal of clinical pharmacology

authors： Wang B,Lau YY,Liang M,Vainshtein I,Zusmanovich M,Lu H,Magrini F,Sleeman M,Roskos L

更新日期：2012-08-01 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：:Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase-1 (COX-1), thereby inhibiting platelet function via blockade of thromboxane A2 (TxA2) formation, and COX-2, the enzyme that mediates inflammatory responses. Meloxicam is a relatively COX-2-selective anti-arthritis drug that shows significant TxA2 inh...

journal_title：Journal of clinical pharmacology

authors： Rinder HM,Tracey JB,Souhrada M,Wang C,Gagnier RP,Wood CC

更新日期：2002-08-01 00:00:00

abstract：:The pharmacokinetic profile of solifenacin succinate (YM905; Vesicare), a new once-daily bladder-selective muscarinic receptor antagonist, was examined in 2 controlled trials of healthy young men. A single-dose study evaluated 5-, 10-, 20-, 40-, 60-, 80-, and 100-mg doses. A multidose study evaluated 5-, 10-, 20-, and...

journal_title：Journal of clinical pharmacology

authors： Smulders RA,Krauwinkel WJ,Swart PJ,Huang M

更新日期：2004-09-01 00:00:00

abstract：:Chemotherapy-induced nausea and vomiting (CINV) is a common treatment-related adverse event that negatively impacts the quality of life of cancer patients. During pediatric drug development, extrapolation of efficacy from adult to pediatric populations is a pathway that can minimize the exposure of children to unneces...

journal_title：Journal of clinical pharmacology

authors： Momper JD,Heinrichs MT,Krudys K,Griebel D,Kumar S,Kim I,Mehrotra N,Mulberg AE,Garimella N,Nelson R,Reaman G,Sinha V,Yao L,Zineh I,Burckart G,Sachs H,Mulugeta Y

更新日期：2020-06-01 00:00:00