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International Journal of Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/30220294/tea-consumption-and-risk-of-breast-cancer-a-meta-analysis
#1
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/30220293/evaluation-of-reference-scaled-average-bioequivalence-of-two-oral-formulations-of-abiraterone-acetate-in-healthy-chinese-subjects
#2
Cuiyun Li, Yanhua Ding, Deming Yang, Meng Wang, Yue Hu, Hong Zhang, Xiaoxue Zhu, Guiling Chen, Xiaojiiao Li, Min Wu, Jingrui Liu, Hong Chen, Chengjiao Liu, Zhenwei Shen, Bin Liu
OBJECTIVE: This study was designed to evaluate the pharmacokinetic (PK) properties and bioequivalence (BE) of two 250-mg tablet formulations of abiraterone acetate: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult Chinese subjects under fasted (n = 40) and fed (n = 40) conditions. MATERIALS AND METHODS: The comparison was performed using a single-dose, open, randomized, and four-way replicate study. The concentration of abiraterone in blood samples taken over 48 hours was determined by liquid chromatography tandem mass spectrometry (LC-MS/MS)...
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
#3
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
#4
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
#5
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
#6
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
https://www.readbyqxmd.com/read/30178742/pharmacodynamic-effects-of-voglibose-administered-alone-administered-with-metformin-and-administered-with-metformin-in-a-fixed-dose-combination-in-healthy-korean-subjects
#7
Ho-Sook Kim, Minkyung Oh, Eun Ji Kim, Geun Seog Song, Eun-Young Kim, Jae-Gook Shin
OBJECTIVE: This study aimed at exploring the effects of metformin on the pharmacodynamics of voglibose, while investigating the pharmacodynamics between a fixed-dose combination (FDC) of voglibose/metformin and coadministered doses of voglibose and metformin tablets in healthy Korean subjects. MATERIALS AND METHODS: A randomized, open-label, 2×3×3 crossover study with a 9-day washout period was conducted in 30 healthy subjects. All subjects received orally administered voglibose alone, individual voglibose and metformin tablets, or FDC 3 times daily for 5 days...
September 4, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30168416/bioequivalence-study-of-the-antiepileptic-drug-levetiracetam-in-concentrated-solution-for-injection-versus-oral-tablets-in-healthy-chinese-subjects-under-fasting-conditions-a-randomized-open-label-three-way-crossover-study
#8
Junyu Xu, Xia Zhao, Zining Wang, Ying Zhou, Xiaoqin Yang, Yimin Cui
OBJECTIVE: The objective of this study was to evaluate the bioequivalence between single-dose intravenous (IV) infusion injection (the infusion time was 15 minutes and 45 minutes) and tablets of 1,000 mg levetiracetam in healthy Chinese male subjects. MATERIALS AND METHODS: This was a randomized, open-label, three-way crossover bioequivalence study. All of the 24 healthy male subjects received a treatment of 45-minute IV infusion, 15-minute IV infusion, and oral tablets...
August 31, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30168415/randomized-double-blind-placebo-controlled-phase-i-study-of-the-safety-and-pharmacokinetics-of-namilumab-in-healthy-japanese-and-caucasian-men
#9
Shingo Tanaka, Sayaka Harada, Naoto Hiramatsu, Ryou Nakaya, Masaki Kawamura
OBJECTIVE: Namilumab is an investigational human monoclonal antibody to human granulocyte-macrophage colony-stimulating factor (GM-CSF). A phase I study of repeated namilumab dosing (150 or 300 mg subcutaneously) in non-Japanese patients with rheumatoid arthritis reported no safety concerns. The objective of this study was to report the safety (primary endpoint) and pharmacokinetic/pharmacodynamic effects of namilumab in healthy Japanese and Caucasian men aged 20 - 45 years (NCT02354599)...
August 31, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30148451/adverse-effects-of-chronic-nicotine-exposure-on-the-kidney-potential-human-health-implications-of-experimental-findings
#10
Istvan Arany, Mary Taylor, Tibor Fülöp, Mehul Dixit
With the increasing popularity of E-cigarettes, chronic exposure to nicotine (NIC) is emerging as a novel risk factor for the kidney. NIC increases oxidative stress in the kidneys, which impairs the viability and function of renal tubular and endothelial cells, alters renal hemodynamics, and compromises overall kidney function. Moreover, long-term NIC exposure increases the risk of development and progression of chronic kidney diseases and may escalate the impact of coexisting morbidities such as obesity-associated renal disease, hypertension, renal transplant status, or the toxicity of various anticancer agents...
August 27, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30148450/efficacy-and-safety-of-a-fixed-dose-combination-of-d-norpseudoephedrine-triiodothyronine-atropine-aloin-and-diazepam-in-obese-patients
#11
Cecilia Fernández Del Valle-Laisequilla, Cristian Trejo-Jasso, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Rodríguez-Silverio, Héctor Isaac Rocha-González, Juan Gerardo Reyes-García
OBJECTIVE: A fixed-dose combination (FDC) of D-norpseudoephedrine, tri-iodothyronine, atropine, aloin, and diazepam is used in Mexico for the short-term treatment of obesity; however, its efficacy and safety have been scarcely studied. The aim of this study was to analyze the efficacy and safety of this FDC in Mexican adult overweight and obese patients by a prospective, uncontrolled, multicenter, phase IV open-label study. MATERIALS AND METHODS: 3,290 patients with a body mass index (BMI) ˃ 27 kg/m2 were included in the current study...
August 27, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30106363/development-of-clinical-pharmacy-services-in-australia-austria-belgium-bosnia-herzegovina-canada-germany-japan-kosovo-switzerland-the-netherlands-thailand-usa-and-correlation-with-educational-standards-level-of-research-and-implemen
#12
Olaf Rose, Hartmut Derendorf, Susanne Erzkamp, Kenji Fujita, Alexander Hartl, Kreshnik Hoti, Ines Krass, Emina Obarcanin, Jan Saevels, Pornchanok Srimongkon, Martina Teichert, Ross T Tsuyuki
OBJECTIVE: This study aimed to compare determinants of professional development between different countries to identify barriers and facilitators of development towards clinical pharmacy services and stimulate discussion of under-used potential and opportunities. MATERIALS: The study was conceived as a survey. The questionnaire was administered to a group of experts. METHODS: The survey was conducted as a cross-sectional study with descriptive and correlation analysis...
August 14, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30049305/effect-of-nasally-exhaling-budesonide-formoterol-dry-powder-inhaled-at-fast-inspiratory-flow-on-eosinophilic-chronic-rhinosinusitis
#13
Satoshi Hamada, Daiki Hira, Yoshiki Kobayashi, Hirotaka Yasuba
BACKGROUND: Budesonide (BUD)/formoterol (FM) dry powder inhaler has a feature that the fine particle fraction output is dependent on users' inspiratory flow rate. The aim of this study was to assess the amount of nasally exhaled BUD/FM inhaled in the different inspiratory flow rate. We also examined the effect of nasal exhalation of BUD/FM dry powder inhaled on radiographic evidence of sinonasal inflammation in asthmatic patients with eosinophilic chronic rhinosinusitis (ECRS). MATERIALS AND METHODS: The quantitative amount of nasally exhaled BUD/FM was analyzed by high-performance liquid chromatography in 3 healthy subjects...
July 27, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30021691/comparisons-of-the-pharmacokinetics-and-tolerability-of-a-fixed-dose-combination-of-montelukast-levocetirizine-with-separate-tablets
#14
Seokuee Kim, Jae-Wook Ko, Jung-Ryul Kim
OBJECTIVE: A novel fixed-dose combination (FDC) capsule of 10/5 mg of montelukast/levocetirizine may lead to better compliance than two separate tablets taken together. The aim of this study was to evaluate the pharmacokinetics (PK) and tolerability of an FDC of montelukast and levocetirizine compared to separate tablets. MATERIALS AND METHODS: A randomized, open-label, single-dose, two-sequence, two-period, crossover study was conducted with healthy male subjects...
July 19, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30021690/a-dose-ranging-study-of-a-tablet-formulation-of-orlistat
#15
Susan M Schwartz, David M Savastano
OBJECTIVE: Examine inhibition of dietary fat absorption with orlistat tablets (24, 36, 48, 72, and 144 mg) vs. 60-mg orlistat capsule. MATERIALS AND METHODS: 83 overweight/obese subjects randomized to 1 of 6 open-label treatments. Pre- vs. post-treatment fecal fat analysis was conducted. RESULTS: Mean percent fecal fat (60-mg capsule, 16.8%; 48-mg tablet, 16.5%) was similar (ratio of geometric mean and 90% CI: 60-mg capsule/48-mg tablet, 1...
July 19, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30168417/basic-characteristics-and-representativeness-of-the-german-disease-analyzer-database
#16
Wolfgang Rathmann, Brenda Bongaerts, Hans-Joachim Carius, Silvia Kruppert, Karel Kostev
PURPOSE: The aim of this study was to evaluate the representativeness of diagnoses in the Disease Analyzer (DA) database for major chronic diseases (cancer, dementia, diabetes). MATERIALS AND METHODS: DA contains anonymized longitudinal data on drug prescriptions, diagnoses as well as medical and demographic data directly obtained from the computer system of a representative sample of practices throughout Germany. DA contains data from 2,498 practices with 7.8 million patients (2017)...
October 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30106362/capecitabine-bioequivalence-in-healthy-volunteers
#17
Mariana Machado Matos, Renan Arthur Bosio-Guimarães, Ana Júlia Schmidt Niederauer, Katia Isabel Fercondini Pastre, Ronilson A Moreno, Simone Grigoletto Schramm, Paulo Alexandre Rebelo Galvinas, Gustavo D Mendes, Gilberto De Nucci
Capecitabine is a prodrug and is selectively activated by tumor cells to its cytotoxic moiety, 5-fluorouracil, by thymidine phosphorylase, which is generally expressed at high levels in tumors. Clinical and pharmacokinetic studies of capecitabine have been performed in patients with cancer. This study aims to evaluate the bioequivalence of two capecitabine formulations (150-mg tablet) using healthy male subjects under nonfasting conditions. The study was conducted as an open, randomized, three-period, semi-replicated design with three sequences (RRT, RTR, TRR) with a 1-week washout interval...
October 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30079887/determination-of-lacidipine-in-human-plasma-by-lc-ms-ms-application-in-a-bioequivalence-study
#18
Hao Chen, Lan Li, Shuai Song, Yan Du, Xiaoqin Jin, PeiPei Ding, Chenlin Shen, Xiaohui Huang
OBJECTIVE: This study aimed to conduct a sensitive, simple, and reliable liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantification of lacidipine in human plasma. MATERIALS AND METHODS: In this method, the plasma samples were extracted from human plasma using methanol as the precipitant and nisoldipine as internal standard (IS). The analytes were separated on a Phenomenex Luna C18 column (150 mm × 2.0 mm, 3 µm) at 40 °C using isocratic mobile phase consisting of 0...
October 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30049303/effect-of-coadministration-of-metformin-with-mirogabalin-results-from-a-phase-1-randomized-open-label-drug-drug-interaction-study
#19
James Dow, Alexander Currie, Ling He, Faisal Zaidi, Hamim Zahir
Mirogabalin, a selective voltage-dependent calcium channel α2δ ligand under development for treatment of neuropathic pain, may be coadministered with metformin in patients with type 2 diabetes mellitus who have diabetic peripheral neuropathic pain. A randomized, open-label, single-dose, 3-treatment, 3-period crossover study evaluated the pharmacokinetics (PK) and safety of mirogabalin and metformin upon coadministration. Eligible subjects received 3 treatments separated by a 7-day washout period: 1 oral dose of mirogabalin 15 mg; 1 oral dose of metformin 850 mg; and coadministration of mirogabalin 15 mg with metformin 850 mg...
October 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29974857/baclofen-induced-neurotoxicity-in-patients-with-compromised-renal-function-review
#20
Sohail Abdul Salim, Litty Thomas, Anand Achanti, Monika Beck Gööz, Jorge Castaneda, István Arany, Albert W Dreisbach, Tibor Fülöp
Baclofen is a centrally-acting γ-amino butyric acid agonist used mainly in the symptomatic management of spasticity originating from the spinal cord. It is absorbed completely from the gastrointestinal tract, metabolized by the liver to a minor degree, and excreted unchanged by the kidneys. Baclofen is moderately lipophilic and can cross the blood-brain barrier easily. At the usual dosage, it acts mainly at the spinal level without central nervous system (CNS) side effects. During renal failure, however, the elimination of the drug will decrease with a prolonged half-life, resulting in a larger area-under-the-curve exposure and disproportionate CNS toxicity...
October 2018: International Journal of Clinical Pharmacology and Therapeutics
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