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International Journal of Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/30431426/bioequivalence-of-fluticasone-propionate-and-salmeterol-fs-given-by-the-fs-spiromax%C3%A2-and-seretide-accuhaler%C3%A2-systems
#1
Denise Wayne, Harald Iverson, Michael Gillespie, Edward Hellriegel, Calvin Small
OBJECTIVE: To determine pharmacokinetic (PK) profiles of fluticasone propionate (FP) and salmeterol (SAL) in healthy volunteers following administration as two inhalations from the FS Spiromax 500/50 µg and Seretide Accuhaler 50/500 µg inhalers, without (study 1, n = 79) and with charcoal block (study 2, n = 77). Safety was also assessed. MATERIALS AND METHODS: In two single-center, open-label, randomized two-period crossover studies, PK parameters were calculated from plasma drug concentrations obtained pre-dose through 36 hours post-dose...
November 15, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30431425/the-association-between-clopidogrel-and-2-oxo-clopidogrel-plasma-levels-and-the-long-term-clinical-outcome-after-acute-myocardial-infarction
#2
Milan Pavlovic, Svetlana Apostolovic, Dragana Stokanovic, Jelena Lilic, Sandra S Konstantinovic, Jelena B Zvezdanovic, Valentina N Nikolic
BACKGROUND AND OBJECTIVES: A significant number of ischemic events occur after acute myocardial infarction (MI), even when adhering to dual antiplatelet therapy including aspirin and clopidogrel. The aim of our study was to investigate the association between the concentration of the prodrug clopidogrel and its intermediary metabolite 2-oxo-clopidogrel plasma as well as demographic and clinical factors, and the long-term clinical outcome in patients with their first acute MI, ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction NSTEMI, treated with percutaneous coronary intervention (PCI)...
November 15, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30415650/pharmacokinetic-and-bioequivalence-study-of-sugar-coated-and-film-coated-eperisone-tablets-in-healthy-subjects-a-randomized-open-label-three-way-reference-replicated-crossover-study
#3
Hyun-Ju Lee, Eun-Sol Ha, Yoonseo Lee, Dae-Chul Ha, Youn-Woong Choi, In-Hwan Baek, Min-Soo Kim
OBJECTIVE: Eperisone hydrochloride is used in the treatment of musculoskeletal disorders as a muscle relaxant via blocking of calcium channels. In this study, we aimed to investigate the within-subject variability (CVwR ) of reference eperisone formulation for highly-variable drugs and to perform bioequivalence study of two oral formulations (sugar- and film-coated tablets) of eperisone hydrochloride 50 mg in healthy subjects by reference-replicated crossover study. MATERIALS AND METHODS: 36 healthy Korean male subjects were recruited, and 33 subjects completed the study...
November 12, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30378536/donepezil-decreases-heart-rate-in-elderly-alzheimer-s-disease-patients
#4
Zhengping Pu, Wenjie Xu, Yong Lin, Juanhui Shen, Yunying Sun
OBJECTIVE: Donepezil is an acetylcholinesterase inhibitor (AChI) that improves cognitive function in Alzheimer's disease (AD) patients. However, AChIs are usually associated with peripheral adverse reactions. Here, we investigated the cardiac outcomes in elderly AD patients treated with donepezil. MATERIALS AND METHODS: A total of 82 AD patients (age, 75.47 ± 6.53 years) received 5 mg or 10 mg donepezil (n = 41/group) once daily for 12 weeks. Next, we examined the heart rate (HR), cardiac rhythm, and PR, QRS, and QTc intervals...
October 31, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30369397/pill-count-and-the-arithmetic-of-risk
#5
Barry G Woodcock
No abstract text is available yet for this article.
October 26, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30369396/safety-of-intravitreal-injections-non-inferiority-of-bevacizumab-compared-with-ranibizumab
#6
Marco Chiumente, Vera Damuzzo, Laura Agnoletto, Luca Leonardi, Daniele Mengato
No abstract text is available yet for this article.
October 26, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30369395/pill-count-and-the-arithmetic-of-risk-evidence-that-polypharmacy-is-a-health-status-marker-rather-than-a-predictive-surrogate-for-the-risk-of-ades
#7
Walter E Haefeli, Andreas D Meid
With advancing age there is an increase in the disease burden and thus in the number of drugs prescribed to this patient group. It is often assumed that an increase in pill count is associated per se with an increase in the number of medication errors (e.g., potentially inappropriate prescribing, PIP) and the frequency of adverse drug events (ADE). However, prescribing more drugs can also mean more successful treatment, making it important to critically assess the benefit/risk balance of the medications prescribed in each patient...
October 26, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30369394/insulin-depot-absorption-modeling-and-pharmacokinetic-simulation-with-insulin-glargine-300-u-ml
#8
Klaus Lindauer, Reinhard Becker
OBJECTIVE: Mathematical models of insulin absorption have been used to predict plasma insulin concentrations after administration, but few are specifically applicable to insulin glargine, which precipitates subcutaneously after injection. MATERIALS AND METHODS: The formation and redissolution of subcutaneous depots of insulin glargine 100 U/mL (Gla-100) and insulin glargine 300 U/mL (Gla-300) are modeled. Surface-area-dependent redissolution is introduced to established diffusion and absorption pathways, and pharmacokinetic (PK) profiles are simulated and subsequently validated using experimental data from euglycemic glucose clamp studies...
October 26, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30336808/pharmacokinetics-and-safety-of-transdermal-and-oral-granisetron-in-healthy-chinese-subjects-an-open-label-randomized-crossover-study
#9
Rui Chen, Xia Chen, Hongyun Wang, Wen Zhong, Eun Sil Oh, Min Soo Park, Yuji Kumagai, Li Zhou, Fumiko Nagahama, Pei Hu
AIMS: To examine the pharmacokinetics and safety of granisetron during transdermal delivery and oral administration to healthy Chinese male subjects. MATERIALS AND METHODS: A single 34.3 mg/52 cm2 transdermal delivery patch of granisetron and the 1-mg tablet of granisetron were dosed to subjects in an open-label, randomized, crossover study. Two dosing schemes were established: scheme 1, in which the 5-day oral administration phase of the tablet (the OA phase) (twice daily every 12 hours) was conducted, followed by the 6-day transdermal delivery phase of the patch (the TD phase); and scheme 2, in which these two phases were conducted in reverse order...
October 19, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30336807/clozapine-drug-induced-pancreatitis-of-intermediate-latency-of-onset-confirmed-by-de-challenge-and-re-challenge
#10
Christina E DeRemer, Benjamin J Andrick, Marie D Capito
Definitive causality for medication-induced illnesses is difficult to determine, as often there are other causes for the condition. Additionally, for disease management there are often alternative treatment paths, and it is therefore clinically unnecessary to re-challenge with the suspected drug causing an adverse reaction; however, that was not the case in this clinical situation. Providers augmented treatment for this patient, but returned to the only therapy that controlled her condition, clozapine, as there appeared to be limited suitable alternatives...
October 19, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30336806/vitamin-d-is-a-potential-antidepressant-in-psychiatric-outpatients
#11
Khalid K Abdul-Razzak, Safa'a O Almanasrah, Bayan A Obeidat, Aws G Khasawneh
BACKGROUND: Anxiety and depression are globally-common disorders. In Jordan, the number of people visiting psychiatric clinics has been increasing over the past few years. Low level of vitamin D is associated with musculoskeletal pain (MSP) and is increasingly linked to the pathology of mental disorders. OBJECTIVE: To assess the prevalence of vitamin D deficiency among psychiatric outpatients and their response to vitamin D supplementation. MATERIALS AND METHODS: 74 outpatients and gender- and age-matched controls were involved...
October 19, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30336805/a-phase-i-randomized-open-label-single-dose-3-period-crossover-study-to-evaluate-the-drug-drug-interaction-between-zx008-fenfluramine-hcl-oral-solution-and-a-regimen-of-stiripentol-clobazam-and-valproate-in-healthy-subjects
#12
Brooks Boyd, Steven Smith, Arnold Gammaitoni, Bradley S Galer, Gail M Farfel
OBJECTIVE: Phase I, open-label, randomized, single-dose, 3-period crossover study assessing pharmacokinetics (PK) and safety of ZX008, a liquid oral formulation of fenfluramine (FFA) under development for adjunctive treatment of Dravet syndrome and Lennox-Gastaut syndrome, administered with and without a combined antiepileptic drug (AED) regimen of stiripentol (STP), valproate (VPA), and clobazam (CLB) (STP regimen). MATERIALS AND METHODS: 26 healthy adults were administered the following treatments: ZX008 0...
October 19, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30336804/a-polypharmacy-risk-prediction-model-for-elderly-patients-based-on-sociodemographic-and-clinical-factors
#13
María Isabel Santos-Pérez, Inmaculada Fierro, M Esther Salgueiro-Vázquez, María Del Mar Gallardo-Lavado, María Sáinz-Gil, Luis H Martín-Arias
OBJECTIVE: Elderly people take increasing amounts of medication. The aim of our study was to determine the effects of different sociodemographic and clinical factors on polypharmacy and to develop a risk prediction model in outpatients aged 65 years and older. MATERIALS AND METHODS: Cross-sectional, observational, descriptive study of outpatients aged 65 years and older scheduled for a specialist visit. Data on sociodemographic (age, sex, place of residence, and institutionalization) as well as on clinical variables (number of prescribing physicians and number of diagnoses) were collected...
October 19, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30309450/effect-of-purple-grape-juice-on-the-pharmacokinetics-of-digoxin-results-of-a-food-drug-interaction-study
#14
Xia Song, Yang Ju, Hui Zhao, Wen Qiu
OBJECTIVE: Digoxin is a glycosidic, cardiotonic plant extract with a narrow therapeutic window. The purpose of the study was to investigate the effects of purple grape juice on the pharmacokinetics of digoxin in rats. MATERIALS AND METHODS: A randomized, controlled, single- and multiple-dose study was conducted to evaluate the pharmacokinetic profiles of orally and intravenously administered digoxin. The plasma concentration of digoxin was determined by radioimmunoassay using a gamma counter, and a Caco-2 cell transport model was used to investigate the potential mechanism by which purple grape juice affects the pharmacokinetics of digoxin...
October 12, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30232958/pharmacokinetics-and-safety-of-salbutamol-ambroxol-fixed-dose-combination-granules-in-healthy-chinese-subjects
#15
Yan Wang, Jin Lu, Tengfei Li, Shunbo Zhao, Wen Yang, Lingye Liu, Xing Shi, Mtalimanja Michael, Li Ding
OBJECTIVES: The aim of the study was to investigate the pharmacokinetics and tolerability of salbutamol/ambroxol fixed-dose combination granules following single and multiple dosing in healthy Chinese subjects. MATERIALS AND METHODS: This was a randomized, open-label, two-period, one-sequence study (n = 12). Each subject received a single oral dose in period 1 and multiple doses in period 2. Plasma concentrations of these two components were determined using a validated LC-MS/MS method...
September 20, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30220294/tea-consumption-and-risk-of-breast-cancer-a-meta-analysis
#16
Shao-Kang Wang, Hong-Mei Xiao, Hui Xia, Gui-Ju Sun
No abstract text is available yet for this article.
September 17, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30220292/changes-in-blood-concentration-of-mycophenolic-acid-and-fk506-in-a-heart-transplant-patient-treated-with-plasmapheresis
#17
Shoji Kawauchi, Kyoichi Wada, Akira Oita
OBJECTIVE: Prior to heart transplant, sensitization to human leukocyte antigen can occur after blood transfusions used during implantation of ventricular assist devices. The result is an increased risk of antibody-mediated rejection (AMR) after heart transplant. While plasmapheresis (PPH) treats serious AMR cases, what subsequent changes occur in the blood concentrations of immunosuppressive agents is still unknown. We investigated pre- and post-PPH changes in blood concentrations of tacrolimus (FK506) and mycophenolic acid (MPA) in a heart-transplant patient experiencing AMR...
September 17, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30220291/predictability-of-serum-vancomycin-concentrations-using-the-kinetic-estimated-glomerular-filtration-rate-formula-for-critically-ill-patients
#18
Dai Harada, Shigehiko Uchino, Takashi Kawakubo, Masanori Takinami
OBJECTIVE: To evaluate the predictability of serum vancomycin concentrations of critically ill patients using the new kinetic estimated glomerular filtration rate (KeGFR) and other three established eGFR formulae. MATERIALS AND METHODS: We calculated serum vancomycin concentrations using software provided by the manufacturer of vancomycin. RESULTS: Data were collected from 122 hospitalized adults. The mean error and mean absolute error of KeGFR were 0...
September 17, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30220290/time-to-onset-of-cold-and-flu-symptom-relief-a-randomized-double-blind-placebo-controlled-pilot-study-for-a-multisymptom-combination-product
#19
Yi Zhang, Pascal Mallefet
OBJECTIVE: Evaluate effects of a multisymptom tablet on cold and flu symptoms within 4 hours post-administration. MATERIALS AND METHODS: This was a randomized, double-blind, placebo-controlled study in adults with cold and flu symptoms. Eligible participants with at least moderate common cold or flu symptoms and symptom onset ≤ 48 hours before screening were assigned to a single multiple-active-ingredient tablet (containing paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate) or placebo tablet...
September 17, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30178743/effect-of-xyrem-on-locus-coeruleus-activity-as-measured-by-pupillometry-in-a-patient-with-narcolepsy
#20
Steven T Szabo, Kelly Kandra, Andrew D Krystal
No abstract text is available yet for this article.
September 4, 2018: International Journal of Clinical Pharmacology and Therapeutics
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