16 results match your criteria: "Clinical Research Planning Department[Affiliation]"
Int J Clin Oncol
February 2017
Thoracic Center, St Luke's International Hospital, Chuo-ku, Tokyo, Japan.
Int J Clin Oncol
February 2017
Thoracic Center, St Luke's International Hospital, Chuo-ku, Tokyo, Japan.
Background: In Japan, the clinical efficacy of erlotinib monotherapy in epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer was demonstrated in the phase II JO22903 trial, which reported a median progression-free survival of 11.8 months. Here we report final overall survival data from JO22903.
View Article and Find Full Text PDFPain
September 2016
Department of Neuropsychiatry, St. Marianna University School of Medicine, Miyamae-ku, Kawasaki, Japan, M. Murakami is now with the Sanno Hospital, International University of Health and Welfare, Tokyo, Japan.
To evaluate the efficacy and safety of mirtazapine in Japanese patients with fibromyalgia (FM), a parallel-group, randomized, double-blind, placebo-controlled phase IIa study was conducted at 57 sites between November 2012 and February 2014. Patients aged 20 to 64 years who met the American College of Rheumatology 1990 diagnostic FM criteria and had stably high pain scores during a placebo run-in period were randomly assigned (1:1) by a computer-generated allocation sequence (block size 4) to receive mirtazapine orally (15 mg/d for 1 week and then 30 mg/d) or matching placebo for 12 weeks. The primary endpoint was change in mean numerical rating scale (NRS) pain score from baseline to endpoint (week 12 or early discontinuation).
View Article and Find Full Text PDFBioDrugs
February 2016
Sugioka Memorial Hospital, Souseikai, Fukuoka, Japan.
Background: DMB-3111 is a biosimilar trastuzumab drug being jointly developed by Meiji Seika Pharma (Japan) and Dong-A Socio Holdings (Korea). We investigated the bioequivalence of DMB-3111 relative to trastuzumab.
Objectives: The aim of this study was to investigate the bioequivalence between DMB-3111 and trastuzumab and the pharmacokinetic, safety, and immunogenicity of both drugs in healthy Japanese adult males.
Drug Res (Stuttg)
February 2016
Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Objective: Tofogliflozin is an oral hypoglycemic agent with a novel mechanism of action that reduces blood glucose levels by promoting glucose excretion in urine, achieved by selectively inhibiting sodium-glucose co-transporter 2 (SGLT2). We evaluated the effects of several selected anti-type 2 diabetes mellitus (T2DM) drugs-glimepiride, metformin, sitagliptin, pioglitazone, miglitol, nateglinide, and voglibose-on the pharmacokinetics and pharmacodynamics of tofogliflozin, and the effects of tofogliflozin on the pharmacokinetics of these anti-T2DM drugs in healthy male volunteers.
Methods: A single dose of either tofogliflozin alone, one of the anti-T2DM drugs alone, or co-administration of tofogliflozin and the anti-T2DM drug was administered to 108 healthy men.
Clin Pharmacokinet
April 2015
Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd, 2-1-1, Nihonbashi Muromachi, Chuo-ku, Tokyo, 103-8324, Japan,
Eur J Drug Metab Pharmacokinet
April 2016
Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd., 2-1-1, Nihonbashi Muromachi, Chuo-ku, Tokyo, 103-8324, Japan.
Ibandronate is a drug widely used outside Japan for the treatment of osteoporosis. It is available in formulations for intermittent intravenous (i.v.
View Article and Find Full Text PDFClin Pharmacokinet
March 2015
Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd, 2-1-1, Nihonbashi Muromachi, Chuo-ku, Tokyo, 103-8324, Japan,
Ibandronate, a nitrogen-containing bisphosphonate, is a bone resorption inhibitor widely used to prevent and treat osteoporosis. To optimize the design for a long-term clinical study of ibandronate, modeling and simulation (M&S) was performed based on the result of population pharmacodynamic analysis using the data of a short-term clinical study. A population pharmacodynamic model was constructed by the urinary C-terminal telopeptide of type I collagen (uCTx) and the lumbar spine bone mineral density (BMD) data obtained in clinical studies, including a phase II study of Japanese osteoporosis patients treated with ibandronate for 6 months.
View Article and Find Full Text PDFJ Clin Pharm Ther
April 2015
Clinical Research Planning Department, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.
What Is Known And Objective: This study aimed to elucidate the pharmacokinetics of erlotinib in Japanese patients with advanced non-small cell lung cancer (NSCLC) and to investigate the relationship between erlotinib exposure and the occurrence of interstitial lung disease (ILD)-like events.
Methods: Population pharmacokinetics analysis was performed using nonlinear mixed-effects modelling software (NONMEM) based on 348 plasma samples from 97 patients obtained in two phase II clinical studies. Individual empirical Bayesian estimates (EBEs) of apparent oral clearance (CL/F) and Cmax were compared between the patients who developed and did not develop ILD-like events.
Drug Metab Dispos
October 2014
Departments of Pharmacology and Pharmacokinetics (A.H.) and Pharmacy (A.T., H.S.), University of Tokyo Hospital, Tokyo, Japan; Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan (M.N.); and Laboratory for Safety Assessment and ADME, Asahi Kasei Pharma Corporation, Tokyo, Japan (S.K.).
In this study, we developed the drug-drug interaction (DDI) method as a new assessment technique of intestinal availability (F(G), the fraction of drug transferred from the intestinal enterocytes into the liver, escaping from intestinal metabolism) based on the clearance theory. This method evaluates F(G) from changes caused by DDIs in the area under the blood concentration-time curve and in the elimination half-life of victim drugs. Application of the DDI method to data from the literature revealed that the mean and S.
View Article and Find Full Text PDFClin Lung Cancer
November 2014
Department of Internal Medicine, Izumi Municipal Hospital, Izumi, Osaka, Japan.
Introduction: Although interstitial lung disease (ILD) is a known serious adverse effect of epidermal growth factor receptor tyrosine kinase inhibitors, the risk factors for its development are poorly defined. To determine the risk factors for the development of drug-induced ILD and poor-prognosis (fatal) drug-induced ILD after erlotinib treatment, we assessed the baseline pulmonary status in patients with non-small cell lung cancer enrolled in a postmarketing clinical study of erlotinib.
Patients And Methods: In the present prospective cohort study, the baseline pulmonary status of all patients was evaluated using conventional or high-resolution computed tomography.
Drug Metab Pharmacokinet
February 2015
Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd.
Orlistat is used clinically worldwide as anti-obesity drug. It is a chemically synthesized hydrogenated derivative of lipstatin and is an inhibitor of gastric and pancreatic lipases. It has been found to reduce the absorption of dietary fat in the gastrointestinal tract.
View Article and Find Full Text PDFJ Clin Pharmacol
May 2014
DMCP, Clinical Research, Bristol-Myers K.K., Tokyo, Japan.
Ethnic evaluation of the pharmacokinetics and safety of new drugs is required in Japan before implementing bridging or joining global studies. As therapeutic monoclonal antibodies (mAbs) show limited ethnic differences, their pharmacokinetics and safety in Japanese individuals could be estimated from prior non-Japanese studies. Therefore, there is potential to re-evaluate the development program for mAbs in Japan.
View Article and Find Full Text PDFPharm Stat
April 2014
Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
There is a growing need for study designs that can evaluate efficacy and toxicity outcomes simultaneously in phase I or phase I/II cancer clinical trials. Many dose-finding approaches have been proposed; however, most of these approaches assume binary efficacy and toxicity outcomes, such as dose-limiting toxicity (DLT), and objective responses. DLTs are often defined for short time periods.
View Article and Find Full Text PDFJ Chromatogr B Analyt Technol Biomed Life Sci
November 2011
Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd., Kamakura, Kanagawa, Japan.
A robust and sensitive method using liquid chromatography-tandem mass spectrometry was developed and validated for the simultaneous determination of a novel topoisomerase 1 inhibitor CH0793076 (3076), the prodrug CH4556300 (TP300), and the active metabolite CH0793011 (3011) in human plasma. All plasma analyzed with this method was acidified with 1M HCl and 46% citric acid solution in a ratio of 100:10:1 (v:v:v) to avoid the pH-based degradation of TP300 and to shift the equilibria of 3076 and 3011 between the lactone and carboxylate forms towards the lactone forms. After the plasma proteins were precipitated with methanol:acetonitrile:HCl 1M (50:50:1, v:v:v) containing stable isotopic internal standards, the analytes were trapped on an Xterra MS C18 column (10×2.
View Article and Find Full Text PDFClin Calcium
January 2011
Medical Writing group 2, Clinical Research Planning Department, Chugai Pharmaceutical Company Limited.
Ibandronate is a potent nitrogen-containing bisphosphonate and is a convenient therapeutic drug for osteoporosis because ibandronate can be administrated once a month or at much longer interval by orally or intravenously (bolus injection). In BONE study, that is a large-scale pivotal study on fracture with osteoporosis patients, efficacy to prevent the incidence of new vertebral fracture was shown in both regimen of 2.5 mg daily and 20 mg intermittent oral administration.
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