Abstract:
BACKGROUND AND OBJECTIVES:Oxycodone tamper resistant (OTR) is a new extended-release abuse-deterrent formulation providing improvements in the tamper resistant characteristics. This study aimed to investigate the pharmacokinetic properties of the new OTR tablets and evaluate the bioequivalence of oxycodone from OTR and the original extended release (ER) formulation tablets administered with an opioid antagonist in patients with chronic pain. METHODS:In this open-label, randomized, cross-over study, the enrolled patients were randomised to receive a single dose of 40 mg OTR or 40 mg OXYCONTIN® (OXY) tablet administered with naltrexone blockade under fasting conditions. Serial blood samples for pharmacokinetic analysis were collected. Plasma oxycodone was quantified by a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. Tolerability was evaluated by monitoring adverse events, physical examinations, 12-lead ECG and laboratory tests. RESULTS:A total of 38 patients were enrolled and 33 subjects completed the study. After a single dose of 40 mg tablets, pharmacokinetic results of the new OTR tablet were found to be similar to those of original extended-release oxycodone tablet. OTR 40 mg was bioequivalent to OXY 40 mg and was well tolerated in patients with chronic pain. CONCLUSIONS:The new OTR formulation could provide a new choice in the treatment of chronic pain and reduce the potential for oxycodone abuse. Chictr.org identifier: ChiCTR1800017253.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Luo Z,Miao J,Shu S,Wang Y,Zhu X,Hu C,Shen Ydoi
10.1007/s40261-019-00870-wsubject
Has Abstractpub_date
2020-02-01 00:00:00pages
139-148issue
2eissn
1173-2563issn
1179-1918pii
10.1007/s40261-019-00870-wjournal_volume
40pub_type
杂志文章,随机对照试验abstract:BACKGROUND AND AIM:Gastro-oesophageal reflux disease is a common medical problem that places a significant financial burden on outpatient pharmaceutical expenditure. A substantial proportion of this expenditure can be attributed to the use of proton pump inhibitors (PPIs). The aim of this analysis was to evaluate the c...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525050-00005
更新日期:2005-01-01 00:00:00
abstract::Page 806, column 1, line 3: The text, which previously read. ...
journal_title:Clinical drug investigation
pub_type: 已发布勘误
doi:10.1007/s40261-020-00892-9
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a general concern about the use of multisource (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modified-release formulations of clarithromycin (i.e. the originator Klacid XL and the generic Kl...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200929040-00005
更新日期:2009-01-01 00:00:00
abstract::Androgenetic alopecia (AGA) is characterized by non-scarring follicle miniaturization. Despite the success of approved therapies, commonly reported side effects and the need for continual use has led to the investigation of alternative therapies. The aim of this paper is to critically review the success of off-label, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-00743-8
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Little is known about the effects of the calcium channel antagonist manidipine when it is added as a third drug in non-controlled hypertensive patients with diabetes mellitus receiving dual antihypertensive therapy. The aim of this study was to evaluate the response in terms of blood pressure (...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11587400-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Gemigliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes mellitus. This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability. METHODS:A randomized, open-la...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-014-0184-3
更新日期:2014-06-01 00:00:00
abstract:BACKGROUND:Cutaneous warts are caused by human papilloma virus (HPV) infection. FIT039, a specific inhibitor of CDK9, suppresses the proliferation of DNA viruses in vitro. PURPOSE:We evaluated the safety, plasma concentrations, and efficacy of FIT039 delivered by single application of an adhesive skin patch on normal ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0712-7
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:Although some evidence suggests that women may be at greater risk for hypoglycemia, no conclusion has been reached, and female sex has not been taken into account in antidiabetic drug-induced hypoglycemia. This study aimed to determine whether females are at a higher risk of sulfonylurea (SU)-associated hypo...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0314-6
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Sleep architecture changes with age, both in terms of efficiency and total duration of sleep. Hypnotic benzodiazepines promote rapid onset of sleep, uninterrupted sleep and longer duration of sleep in the absence of carryover sedation the following morning; therefore, these may be appropriate f...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200727050-00003
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Characteristics of nucleoside reverse transcriptase inhibitors (NRTIs) make the drug class susceptible to elimination via continuous veno-venous hemofiltration (CVVH), potentially leading to suboptimal drug concentrations if given at the recommended anephric doses during CVVH. The objective of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0275-9
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:Among the many consequences of loss of CFTR protein function, a significant reduction of the secretion of bicarbonate (HCO3-) in cystic fibrosis (CF) is a major pathogenic feature. Loss of HCO3- leads to abnormally low pH and impaired mucus clearance in airways and other exocrine organs, which suggests that ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-019-00861-x
更新日期:2020-02-01 00:00:00
abstract:BACKGROUND:Multimodal pain therapy including cyclo-oxygenase-2 inhibitors can result in optimal pain management with decreased opioid use and fewer opioid-related adverse events. Patient reported outcomes (PROs) help identify benefits in reduced opioid use and increased pain control. METHODS:In this randomized, double...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11317570-000000000-00000
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Congestion is the main cause of morbidity in patients with heart failure. Treatment of fluid overload is often challenging in everyday clinical practice. OBJECTIVE:The aim of this study was to determine the diuretic effect of acetazolamide in patients with exacerbations of chronic heart failure, in addition...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-017-0577-1
更新日期:2017-12-01 00:00:00
abstract::Positron emission tomographic brain imaging and pathological examination have revealed that a chronic, intracerebral neuroinflammatory response lasting for years after a single brain injury may occur in humans. Evidence suggests the immune signaling molecule, tumor necrosis factor (TNF), is centrally involved in this ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0186-1
更新日期:2014-05-01 00:00:00
abstract:PURPOSE:Deferiprone (DFP), deferasirox (DFX) and deferoxamine (DFO) are used in thalassaemia major (TM) patients to treat chronic iron overload. We evaluated the cost-effectiveness of DFP, compared with DFX and DFO monotherapy, from an Italian healthcare system perspective. METHODS:A Markov model was used over a time ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0496-1
更新日期:2017-05-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and safety of the natural platelet-activating factor receptor antagonist, BN 52021 (ginkgolide B) in the treatment of patients with severe sepsis related to Gram-negative and mixed bacterial infection. DESIGN AND SETTING:Prospective, randomised, double-blind, placebo-controlled, mult...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424030-00002
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract. DA-6034 has been shown to be effective in an IBD model and has demonstrated a good toxicological profile in preclinical studies. This study evaluated the tolerability, safety and pharmacokinetics...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0147-0
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Clinicians must choose between an increasing number of medications for the treatment of pulmonary arterial hypertension (PAH) with different routes of administration, adverse effects, costs and efficacies. We constructed a decision analysis to help inform treatment choices in PAH. METHODS:We c...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11317820-000000000-00000
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVE:To characterise the pharmacokinetics of indinavir during different phases of the menstrual cycle in HIV-infected women. DESIGN:Open-label study. SETTING:The immunodeficiency clinic at Erie County Medical Center, Buffalo, New York. PATIENTS:Ten HIV-infected women were enrolled in the study. Eligibility crit...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200222020-00007
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:As compared with individual tablets, saxagliptin/metformin extended-release (XR) fixed-dose combination (FDC) tablets offer potential for increased patient compliance with the convenience of once-daily dosing. Two bioequivalence studies assessed the fed-state bioequivalence of saxagliptin/metf...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11590290-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a risk that disturbances of activities of daily living (ADL) due to rheumatoid arthritis (RA) are increased by the occurrence of fractures, including vertebral compression fractures and femoral neck fractures, in RA patients receiving oral corticosteroid therapy. Bisphosphonates are mo...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200828030-00002
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:More than 30% of patients with epilepsy have inadequate control of seizures with drug therapy. The goal of this study is to determine the budget impact (BI) of the introduction of brivaracetam to the portfolio of approved drugs in Spain as adjunctive therapy for the treatment of partial-onset e...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0615-z
更新日期:2018-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:First-line bevacizumab-based therapy has been shown to improve outcomes in patients with advanced non-squamous non-small-cell lung cancer (NSCLC). The recent international phase IV SAiL study (a Study of Avastin [bevacizumab] in combination with platinum-containing chemotherapy in patients with...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-012-0001-9
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Mirabegron, a selective β3-adrenoceptor agonist for the treatment of overactive bladder (OAB), is eliminated by renal and metabolic routes. The potential influence of renal or hepatic impairment on the pharmacokinetics of mirabegron was evaluated. METHODS:Two separate open-label, single-dose,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0031-3
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The standard of care for HIV treatment is a three-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) and either a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor (PI) or an integrase strand transfer inhibitor. Darunavir boosted with ritonavi...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0456-1
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:To evaluate the efficacy and safety of bronchoalveolar lavage (BAL) with diluted porcine surfactant in mechanically ventilated term infants with severe acute respiratory distress syndrome (ARDS) due to meconium aspiration syndrome (MAS). METHODS:Eight consecutive mechanically ventilated term infants with se...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626010-00002
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Schizophrenia treatment has been shifting to resocialization by efficacious antipsychotic drugs. However, even some of the pivotal studies of approved new antipsychotic drugs with proven efficacy had failed due to high placebo response. The aim of this study was to identify the potential factor...
journal_title:Clinical drug investigation
pub_type: 杂志文章,meta分析
doi:10.1007/s40261-018-0661-1
更新日期:2018-08-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Tendon rupture can result from fluoroquinolone exposure. The objective of this study was to quantify relative and absolute risk and determine how risk is affected by timing of exposure. METHODS:The UK Health Improvement Network primary care database was used to perform a nested case-control st...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0729-y
更新日期:2019-02-01 00:00:00
abstract:OBJECTIVE:To investigate the efficacy and tolerability of high-dose N-acetylcysteine (NAC) in the treatment of patients with exacerbations of chronic obstructive pulmonary disease (COPD). DESIGN AND PATIENTS:Randomised, double-blind, double-dummy, placebo-controlled study in 123 patients experiencing an acute exacerba...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525060-00005
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Herpes zoster (HZ) and its most frequent complication, post-herpetic neuralgia (PHN), have been shown to considerably impact quality of life (QoL). This has not yet been demonstrated in Japan. METHODS:QoL in HZ and PHN patients was evaluated using the Zoster Brief Pain Inventory (ZBPI), EuroQ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-017-0581-5
更新日期:2018-01-01 00:00:00