journal
MENU ▼
Read by QxMD icon Read
search

International Journal of Clinical Pharmacology and Therapeutics

journal
https://www.readbyqxmd.com/read/28619129/randomized-two-way-crossover-bioequivalence-study-of-levamlodipine-besylate-tablets-in-healthy-chinese-subjects%C3%A2
#1
Su-Mei Xu, Yu-Lu Wang, Dan Li, Xiao-Min Li, Dai Li, Ping-Sheng Xu
OBJECTIVE: The present bioequivalence study was designed to compare the newly-developed levamlodipine besylate 2.5-mg tablet (test) with that of its 2.5-mg marketed counterpart (reference) in healthy Chinese adult male volunteers. METHODS: A single-dose, randomized, open-label, two-period, and two-treatment self-crossover study was conducted in healthy Chinese volunteers after informed consent was obtained. In each part of the study, the subjects were randomly assigned to receive the test or reference product (5 mg levamlodipine) in a 1 : 1 ratio, and then received the alternative product, following a 14-day washout period...
June 16, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28590244/tralokinumab-pharmacokinetics-and-tolerability-when-administered-by-different-subcutaneous-injection-methods-and-rates%C3%A2
#2
Meena Jain, Diane Doughty, Corbin Clawson, Xiaobai Li, Nicholas White, Balaji Agoram, René van der Merwe
OBJECTIVE: Tralokinumab, administered as two 1-mL subcutaneous injections every 2 weeks, at the target dose 300 mg, has been shown to improve lung function in patients with asthma. This study evaluated the pharmacokinetic (PK) and tolerability profile of tralokinumab 300 mg when administered by different rates of subcutaneous injection, as part of a pilot investigation of new injection regimens. METHODS: This phase I study randomized 60 healthy adults to receive 300 mg tralokinumab, as two 1-mL subcutaneous injections, each delivered over 10 seconds, or one 2-mL injection delivered over 10 seconds (12 mL/min), 1 minute (2 mL/min), or 12 minutes (0...
June 7, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28518054/comparison-of-three-estimators-for-determining-cyclosporine-dosing-in-infants-after-liver-transplantation%C3%A2
#3
Dzhem Farandzha, Veneta Dimitrova, Ivanka Atanasova, Lubomir Spassov, Dimiter Terziivanov
OBJECTIVE: To compare and analyze how allometrically- and linearly-scaled daily doses of cyclosporine could affect the therapeutic drug monitoring concentrations when applied to 8 infants with liver transplants. MATERIALS AND METHODS: Eight infants who underwent liver transplantations were put on twice-daily oral cyclosporine immunosuppressive regimens. After starting therapy, the adjustments of individual daily doses were determined by using therapeutic monitoring of plasma cyclosporine levels by measuring trough concentrations (C0) and concentrations at 2 hours after drug administration (C2)...
May 18, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28518053/effects-of-genetic-variants-in-ugt1a1-slco1b3-abcb1-abcc2-abcg2-orm1-on-pk-pd-of-telmisartan-in-chinese-patients-with-mild-to-moderate-essential-hypertension%C3%A2
#4
Qi Pei, Liu Yang, Hong-Yi Tan, Shi-Kun Liu, Yang Liu, Lu Huang, Rong-Hui Li, Qian Wan, Jie Huang, Cheng-Xian Guo, Xiao-Cong Zuo, Jingle Li, Guo-Ping Yang
PURPOSE: This study aimed to understand the effects of single nucleotide polymorphisms (SNPs) in UGT1A1, SLCO1B3, ABCB1, ABCC2, ABCG2, and ORM1 on the pharmacokinetics (PK) (plasma concentration) and pharmacodynamics (PD) (blood pressure) of telmisartan in Chinese patients. METHODS: 58 Han Chinese patients (aged 45 - 72 years) with mild to moderate essential hypertension were included and received 80 mg/day telmisartan for 4 weeks. The plasma concentration and genetic variants were determined by LC/MS/MS and MALDI-TOF mass spectrometry, respectively...
May 18, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28513427/population-pharmacokinetics-of-lyophilized-recombinant-glucagon-like-peptide-1-receptor-agonist-recombinant-exendin-4-re-4-in-chinese-patients-with-type-2-diabetes-mellitus%C3%A2
#5
Yan-Nan Zang, Min-Jie Zhang, Yi-Tong Wang, Chen Wang, Qian Wang, Qing-Shan Zheng, Li-Nong Ji, Wei Guo, Yi Fang
OBJECTIVE: To investigate the population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (rE-4) in Chinese patients with type 2 diabetes mellitus (T2DM) for plasma concentration estimation and individualized treatment. METHODS: Twelve patients with T2DM were enrolled to receive subcutaneous injections of rE-4 at 5 µg twice daily for 84 days. Administration dosage was adjusted from 5 µg to 10 µg twice daily at day 29 in case of glycated albumin (GA) ≥ 17%...
May 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28513426/pharmacokinetics-and-bioequivalence-of-a-pregabalin-150-mg-capsule-in-healthy-thai-subjects%C3%A2
#6
Nantaporn Prompila, Wanna Eiamart, Yaowatree Jumroen, Nonlanee Sayankuldilok, Pajaree Chariyavilaskul, Wannarasami Ketchat, Supeecha Wittayalertpanya
OBJECTIVE: The purpose of the study was to evaluate the pharmacokinetics and bioequivalence of pregabalin following administration of a 150-mg capsule of test and reference products. METHOD: The study was designed as a randomized, two-treatment, two-period, two-sequence, single-dose crossover with 1-week washout period between period I and period II dosing. 20 healthy male and female Thai subjects were enrolled in the study. Each subject was in fasted state for ~ 10 hours prior to receiving a single oral 150-mg pregabalin capsule...
May 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28513425/actual-use-of-and-adherence-to-ibuprofen-400%C3%A2-mg-tablet-dosing-instructions-in-a-simulated-otc-environment%C3%A2
#7
Suzanne Meeves, Rina Leyva, Clark Richardson, Brenda Wilson, David Savastano
OBJECTIVE: Evaluate adherence of US consumers to proposed label directions for a new 400 mg ibuprofen formulation. METHODS: In this single-arm, open-label, multicenter, 30-day study simulating an over-the-counter (OTC)-like environment, US analgesic consumers reviewed proposed product packaging for a new 400 mg ibuprofen formulation and made a purchase decision. Purchasers used the product as needed and recorded use over 30 days. Outcomes included the percentage of participants who exhibited correct or acceptable product use for the primary endpoint (not exceeding 1,200 mg/day > 2 times during the study) or secondary endpoint (not exceeding 400 mg/dose > 2 times during the study) and adherence to the labeled dosing interval of 6 - 8 hours...
May 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28513424/a-review-of-six-methods-for-monitoring-infliximab-concentrations-and-antibodies-to-infliximab%C3%A2
#8
Fang Cao, Hailong Cao, Xiaocang Cao
Anti-TNF-α therapy, such as infliximab (IFX), has profoundly changed treatment to induce and maintain remission for inflammatory bowel diseases patients who do not respond to conventional therapies. Unfortunately, IFX, as a chimeric protein, is potentially immunogenic, and antibodies to infliximab (ATI) may interfere with the pharmacodynamics and pharmacokinetics of the drug, thus resulting in a loss of response for a substantial proportion of patients. The clinical efficacy of IFX is correlated with the levels of IFX and ATI...
May 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28487010/benzodiazepine-prescribing-in-the-elderly-in%C3%A2-germany-and-korea-a-comparison-of-two%C3%A2-observational-studies%C3%A2
#9
Barry Woodcock, Karel Kostev, Ju-Young Shin
OBJECTIVES: To identify differences and similarities in benzodiazepine (BZD) prescribing patterns in elderly patients reported in two separate and independent investigations, one from Germany for the year 2014 and the other from Korea for the year 2013. METHODS: Data on patients over 65 years, who were prescribed at least one BZD, were obtained from population databases. The design and characteristics of the two studies were similar. RESULTS: The use of BZDs in the elderly in Korea was several-fold higher than in Germany depending on the age stratification...
May 10, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28487009/real-world-prescribing-patterns-of-long-acting-benzodiazepine-for-elderly-koreans-in-2013%C3%A2
#10
So Yun Park, SeungJin Bae, Ju-Young Shin
OBJECTIVE: We aimed to estimate the prevalence of prescriptions to long-acting benzodiazepines (BZDs) among elderly outpatients in Korea in 2013 and analyze the factors that led to inappropriate prescription practices. METHODS: Using the Korea Health Insurance Review and Assessment Service-National Patients Sample database in 2013, we estimated the pattern of BZD prescription among elderly outpatients. BZDs were categorized as long-acting (half-life (T1/2) ≥ 20 hours) or short-acting (T1/2...
May 10, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28438257/pharmacokinetics-and-relative-bioavailability-of-two-allopurinol-tablets-in-healthy-chinese-volunteers%C3%A2
#11
Zhen-Yan Hou, Hua-Lin Cai, Yang Deng, Zhi-Hua Li, Si-Si Cao, Ying Chen, Yao Li, Miao Yan, Bi-Kui Zhang
OBJECTIVE: To evaluate the pharmacokinetics and relative bioavailability of two allopurinol tablets in healthy Chinese volunteers. METHODS: A single-center, randomized, cross-over, two-period study design was conducted in healthy male subjects who were identified as not carrying the HLA-B*58:01 allele. Under fasting conditions, a single oral dose of 300 mg test or reference tablets was given with a 1-week washout period. The blood samples were collected for up to 12 hours after the administration and the plasma concentrations of allopurinol were determined by high performance liquid chromatography...
April 25, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28427498/plasma-and-saliva-concentrations-of-abacavir-tenofovir-darunavir-and-raltegravir-in-hiv-1-infected-patients%C3%A2
#12
Eiko Yamada, Ritsuo Takagi, Yoshinari Tanabe, Hiroshi Fujiwara, Naoki Hasegawa, Shingo Kato
OBJECTIVE: We studied the relationships between plasma and saliva concentrations of antiretroviral drugs to explore whether saliva can be used for therapeutic drug monitoring (TDM). METHODS: Abacavir (ABC), tenofovir (TFV), darunavir (DRV), and raltegravir (RAL) in plasma and saliva from 30 HIV-1-infected patients were quantified using liquid chromatography-tandem mass spectrometry. RESULTS: Mean saliva-to-plasma concentration ratios were 0...
April 21, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28427497/mirtazapine-induced-steatosis%C3%A2
#13
Elin Thomas, Hasan Haboubi, Namor Williams, Aled Lloyd, Chin Lye Ch'ng
Mirtazapine is a commonly used drug indicated for the treatment of severe depression. It works as a presynaptic α2-adrenoreceptor antagonist that increases central noradrenergic and serotonergic neurotransmission, and it is metabolized by the p450 cytochrome oxidase system. There is evidence within the literature to suggest a link between antidepressants and increased liver enzymes, although case reports demonstrating a link between mirtazapine specifically and steatosis are sparse. Here, we present a case of mirtazapine-induced steatosis in a 48-year-old office worker...
April 21, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406092/safety-of-azathioprine-and-6-mercaptopurine-in-patients-with-inflammatory-bowel-disease-na%C3%A3-ve-to-thiopurine-treatment%C3%A2
#14
Ram Alaish, David Lundgren, Ole B Suhr, Mårten Werner, Pontus Karling
OBJECTIVES: To determine if 6-mercaptopurine (MP) is better tolerated than azathioprine (AZA) as the initial thiopurine treatment in patients suffering from inflammatory bowel disease (IBD). Switching patients with IBD from AZA to MP is advocated in patients intolerant to AZA. However, no study has determined if MP is more suited than AZA as a first-line treatment for patients who are naïve to thiopurine treatment. STUDY: The tolerance of AZA and MP treatments in clinical practice was retrospectively evaluated from start to 12 months after initiating treatment in 113 patients with IBD who were all naïve to thiopurines (82 patients treated with AZA and 31 patients with MP)...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406091/daptomycin-associated-eosinophilic-pneumonia-with-rechallenge-a-case-report%C3%A2
#15
Melanie Nickerson, Ashish Bhargava, Pramodini B Kale-Pradhan
PURPOSE: A case of daptomycin-associated acute eosinophilic pneumonia (AEP) with positive rechallenge is reported. SUMMARY: AEP associated with daptomycin is reported in the literature, and the product labeling contains a warning and precaution statement. Criteria for diagnosing daptomycin-induced AEP varies and generally includes bronchoalveolar lavage (BAL) eosinophils ≥ 25%. We report a case of a 70-year-old woman with cough, shortness of breath, and altered mental status who presented ~ 9 days after starting therapy with daptomycin to treat methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406090/pharmacokinetic-comparison-using-two-tablets-of-an-evogliptin-metformin-xr-2-5-500%C3%A2-mg-fixed-dose-combination-vs-1-tablet-each-of-evogliptin-5-mg-and-metformin-xr-1-000-mg%C3%A2
#16
Sumin Yoon, Su-Jin Rhee, Sang-In Park, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, SeungHwan Lee, Kyung-Sang Yu
OBJECTIVES: The aim of this study was to compare the pharmacokinetic (PK) characteristics of evogliptin and metformin following the administration of 2 evogliptin/metformin extended-release (XR) 2.5/500 mg FDC tablets with the coadministration of separate evogliptin 5-mg and metformin XR 1,000-mg tablets (separate formulations). METHODS: A randomized, two-period, two-sequence crossover study was conducted. Subjects were randomly assigned to receive 2 FDC tablets or the individual tablets, followed by a 14-day washout period and the administration of the alternate treatment...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406089/patterns-of-benzodiazepine-prescribing-by-neuropsychiatrists-and-general-practitioners-for-elderly-patients-in-germany-in-2014%C3%A2
#17
Thomas Mell, Louis Jacob, Ida Fuhr, Sandra Dick, Michael A Rapp, Karel Kostev
BACKGROUND: The patterns of benzodiazepine prescriptions in older adults are of general and scientific interest as they are not yet well understood. The aim of this study was to compare the prescription patterns of benzodiazepines in elderly people in Germany to determine the share or proportion treated by general practitioners (GP) and neuropsychiatrists (NP). METHODS: This study included 31,268 and 6,603 patients between the ages of 65 and 100 with at least one benzodiazepine prescription in 2014 from GP and NP, respectively...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406088/population-pharmacokinetics-of-vancomycin-in%C3%A2-chinese-infants%C3%A2
#18
Xiao-Yan Sheng, Chao-Yang Chen, Ling-Yue Ma, Ya-Ou Liu, Ying Zhou, Yi-Min Cui
OBJECTIVE: To determine the pharmacokinetics (PK) of vancomycin in Chinese infant patients using a population pharmacokinetic (PKK) approach in order to provide support for individualized vancomycin therapy. METHOD: The data included 72 sets of steady-state peak and trough serum concentrations from 61 infants (0 - 1 years). PPK analysis was performed using the nonlinear mixed-effects modeling software. Inter- and intraindividual variability was estimated for the clearance and distribution volume of vancomycin...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28372635/trends-in-the-prescribing-of-atypical-antipsychotics-in-elderly-patients-with-dementia-in-korea%C3%A2
#19
Namjoo Seo, Inmyung Song, Heyekyung Park, Dongmun Ha, Ju-Young Shin
OBJECTIVE: In 2005, the Food and Drug Administration warned that atypical antipsychotics (AAPs) increased mortality in elderly patients with dementia. We investigated AAP prescribing in elderly patients with dementia in the ambulatory setting in Korea and the factors affecting AAP prescribing in elderly patients with dementia. METHODS: Subjects ≥ 65 years of age with at least one diagnosis of dementia (ICD-10: F00-F03, G30, G31.8) from January 1 to December 31, 2013 were identified from a health insurance database...
April 4, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28372634/-total-evidence-network-meta-analysis-as-a-tool-for-improving-the-assessment-of-biosimilars-application-to-etanercept-in-rheumatoid-arthritis%C3%A2
#20
Andrea Messori, Sabrina Trippoli, Claudio Marinai
Since biosimilars generally have undergone less clinical research than originators, their place in therapy can be strengthened by increasing the amount of clinical evidence supporting their approval. This report describes an approach in which a "total evidence" network meta-analysis is performed that compares the biosimilar not only with the originator but also with the previous standard of care. This analysis was retrospectively applied to etanercept biosimilar in rheumatoid arthritis (end-point = ACR50)...
April 4, 2017: International Journal of Clinical Pharmacology and Therapeutics
journal
journal
31654
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"