Works matching IS 2160763X AND DT 2019 AND VI 8

Results: 122

Where Can Patients Obtain Information on the Preapproval Access Pathway to Investigational Treatment in Japan? A Survey of Patient Advocacy Organizations' Websites.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 978, doi. 10.1002/cpdd.745

By:

Nakada, Haruka;
Takashima, Kyoko

Publication type:

Article

Effect of Food on the Pharmacokinetics of 2 Formulations of DRL‐17822, a Novel Selective Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Healthy Males.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1042, doi. 10.1002/cpdd.707

By:

Kruithof, Annelieke C.;
Kumar, Rajinder;
Stevens, Jasper;
Kam, Marieke L.;
Gautam, Anirudh;
Alikunju, Shanavas;
Padhi, Bijay K.;
Kulkarni, Swati;
Raghuvanshi, Rajeev S.;
Gandhi, Rajesh;
Burggraaf, Jacobus;
Kamerling, Ingrid M.C.

Publication type:

Article

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Danirixin Hydrobromide Tablets in Japanese Healthy Elderly Participants.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1081, doi. 10.1002/cpdd.693

By:

Iida, Takayuki;
Matsuzawa, Yuki;
Ogura, Hirofumi;
Nagakubo, Takashi;
Wakamatsu, Akira;
Ambery, Claire;
Miller, Bruce E.;
Lazaar, Aili L.;
Numachi, Yotaro

Publication type:

Article

First‐in‐Human Pharmacokinetics and Safety Study of GSK3008356, a Selective DGAT1 Inhibitor, in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1088, doi. 10.1002/cpdd.691

By:

Okour, Malek;
Gress, Angela;
Zhu, Xinyi;
Rieman, David;
Lickliter, Jason D.;
Brigandi, Richard A.

Publication type:

Article

Pharmacokinetic Profile of a Generic Formulation of Sofosbuvir and Its Metabolite GS‐331007 in Healthy Chinese Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1073, doi. 10.1002/cpdd.674

By:

Shen, Zhenwei;
Zhu, Xiaoxue;
Zhang, Hong;
Chen, Hong;
Niu, Junqi;
Chen, Guiling;
Li, Xiaojiao;
Ding, Yanhua

Publication type:

Article

A Phase 3, Randomized, Placebo‐Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1062, doi. 10.1002/cpdd.666

By:

Bergese, Sergio D.;
Melson, Timothy I.;
Candiotti, Keith A.;
Ayad, Sabry S.;
Mack, Randall J.;
McCallum, Stewart W.;
Du, Wei;
Gomez, Alexis;
Marcet, Jorge E.

Publication type:

Article

A Phase 1, Open‐Label, Pharmacokinetic Trial to Investigate Possible Drug‐Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1009, doi. 10.1002/cpdd.665

By:

Morrison, Gilmour;
Crockett, Julie;
Blakey, Graham;
Sommerville, Kenneth

Publication type:

Article

Pharmacokinetics of Once‐Daily Extended‐Release Tacrolimus Tablets Versus Twice‐Daily Capsules in De Novo Liver Transplant.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 995, doi. 10.1002/cpdd.657

By:

DuBay, Derek A.;
Teperman, Lewis;
Ueda, Kimi;
Silverman, Andrew;
Chapman, William;
Alsina, Angel E.;
Tyler, Carmelina;
Stevens, Daniel R.

Publication type:

Article

A Phase 1 Study of Intravenous Plazomicin in Healthy Adults to Assess Potential Effects on the QT/QTc Interval, Safety, and Pharmacokinetics.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1032, doi. 10.1002/cpdd.653

By:

Gall, Jonathan;
Choi, Taylor;
Riddle, Valerie;
Van Wart, Scott;
Gibbons, Jacqueline A.;
Seroogy, Julie

Publication type:

Article

Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ELX‐02, a Potential Treatment for Genetic Disorders Caused by Nonsense Mutations, in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 984, doi. 10.1002/cpdd.647

By:

Leubitz, Andi;
Frydman‐Marom, Anat;
Sharpe, Neal;
Duzer, John;
Campbell, Kathleen C.M.;
Vanhoutte, Frédéric

Publication type:

Article

Elagolix Pharmacokinetic Profiles in Women With Renal or Hepatic Impairment.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 1053, doi. 10.1002/cpdd.640

By:

Ng, Juki;
Duan, W. Rachel;
Marbury, Thomas;
Schmidt, Jeffrey M.;
Klein, Cheri E.

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2019, v. 8, n. 8, p. 973, doi. 10.1002/cpdd.596
Publication type:: Article

Population Pharmacokinetics of Rolapitant in Patients With Chemotherapy‐Induced Nausea and Vomiting.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 850, doi. 10.1002/cpdd.733

By:

Wang, Xiaodong;
Wang, Jing;
Zhang, Zhi‐Yi;
Kansra, Vikram

Publication type:

Article

Bioequivalence of Ertugliflozin/Sitagliptin Fixed‐Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 884, doi. 10.1002/cpdd.722

By:

Fediuk, Daryl J.;
Matschke, Kyle;
Liang, Yali;
Pelletier, Kathleen B.;
Wei, Hua;
Shi, Haihong;
Bass, Almasa;
Hickman, Anne;
Terra, Steven G.;
Zhou, Susan;
Krishna, Rajesh;
Sahasrabudhe, Vaishali

Publication type:

Article

Correction.

Published in:: Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 971, doi. 10.1002/cpdd.719
Publication type:: Article

A Randomized, Placebo‐Controlled Trial to Assess the Effects of 8 Weeks of Administration of GSK256073, a Selective GPR109A Agonist, on High‐Density Lipoprotein Cholesterol in Subjects With Dyslipidemia.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 871, doi. 10.1002/cpdd.704

By:

Olson, Eric J.;
Mahar, Kelly M.;
Haws, Thomas F.;
Fossler, Michael J.;
Gao, Feng;
Gouville, Anne‐Charlotte;
Sprecher, Dennis L.;
Lepore, John J.

Publication type:

Article

Pharmacokinetic Interactions Between the Fixed‐Dose Combinations of Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine and Elbasvir/Grazoprevir in Healthy Adult Participants.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 952, doi. 10.1002/cpdd.702

By:

Feng, Hwa‐Ping;
Guo, Zifang;
Fandozzi, Christine;
Panebianco, Deborah;
Caro, Luzelena;
Wolford, Dennis;
Dreyer, Daniel P.;
Valesky, Robert;
Martinho, Monika;
Rizk, Matthew L.;
Iwamoto, Marian;
Yeh, Wendy W.

Publication type:

Article

Assessment of Drug Interaction Potential Between the Hepatitis C Virus Direct‐Acting Antiviral Agents Elbasvir/Grazoprevir and the Nucleotide Analog Reverse‐Transcriptase Inhibitor Tenofovir Disoproxil Fumarate.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 962, doi. 10.1002/cpdd.701

By:

Feng, Hwa‐Ping;
Guo, Zifang;
Caro, Luzelena;
Talaty, Jennifer E.;
Mangin, Eric;
Panebianco, Deborah;
Fandozzi, Christine;
Zhu, Yali;
Marshall, William;
Huang, Xiaobi;
Hanley, William D.;
Jumes, Patricia;
Valesky, Robert;
Martinho, Monika;
Butterton, Joan R.;
Iwamoto, Marian;
Yeh, Wendy W.

Publication type:

Article

Thorough QTc Evaluation and the Safety of Supratherapeutic Doses of Odanacatib in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 861, doi. 10.1002/cpdd.698

By:

McCrea, Jacqueline;
Mostoller, Kate;
Mahon, Chantal;
Liu, Chengcheng;
Liu, Fang;
Zajic, Stefan;
Panebianco, Deborah;
Chakravarthy, Manu;
Brandquist, Christine;
Gutierrez, Maria;
Stoch, S. Aubrey

Publication type:

Article

Absolute Oral Bioavailability of Glasdegib (PF‐04449913), a Smoothened Inhibitor, in Randomized Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 895, doi. 10.1002/cpdd.692

By:

Shaik, Naveed;
Hee, Brian;
Liang, Yali;
LaBadie, Robert Roland

Publication type:

Article

Study on Drug‐Drug Interactions Between Chiglitazar, a Novel PPAR Pan‐Agonist, and Metformin Hydrochloride in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 934, doi. 10.1002/cpdd.668

By:

Yi, Ling;
Zhang, Hua;
Zhang, Jin‐wen;
You, Xiao‐ming;
Ning, Zhi‐qiang;
Yu, Jia;
Qian, Li‐fang;
Miao, Li‐yan

Publication type:

Article

Use of Population Pharmacokinetic Analyses Among FDA‐Approved Biologics.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 914, doi. 10.1002/cpdd.658

By:

Ogasawara, Ken;
Alexander, G. Caleb

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 845, doi. 10.1002/cpdd.595
Publication type:: Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2019, v. 8, p. i, doi. 10.1002/cpdd.589
Publication type:: Article

The Effect of a High‐Fat Meal on the Pharmacokinetics of Brigatinib, an Oral Anaplastic Lymphoma Kinase Inhibitor, in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 734, doi. 10.1002/cpdd.641

By:

Tugnait, Meera;
Gupta, Neeraj;
Hanley, Michael J.;
Venkatakrishnan, Karthik;
Sonnichsen, Daryl;
Kerstein, David;
Dorer, David J.;
Narasimhan, Narayana

Publication type:

Article

Exposure‐Response Analysis for Efficacy of Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV‐Infected Patients.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 903, doi. 10.1002/cpdd.646

By:

Ueno, T.;
Osawa, M.;
Shiozaki, T.;
Green, M.;
Garimella, T.

Publication type:

Article

Pharmacokinetics, Safety, and Tolerability Evaluation of Single and Multiple Doses of GSK3342830 in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 754, doi. 10.1002/cpdd.637

By:

Tenero, David;
Farinola, Nicholas;
Berkowitz, Elchonon M.;
Tiffany, Courtney A.;
Qian, Yanwen;
Xue, Zhengyu;
Raychaudhuri, Aparna;
Gardiner, David F.

Publication type:

Article

A Phase 1b Trial to Assess the Pharmacokinetics of Ezutromid in Pediatric Duchenne Muscular Dystrophy Patients on a Balanced Diet.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 922, doi. 10.1002/cpdd.642

By:

Muntoni, Francesco;
Tejura, Bina;
Spinty, Stefan;
Roper, Helen;
Hughes, Imelda;
Layton, Gary;
Davies, Kay E.;
Harriman, Shawn;
Tinsley, Jonathon

Publication type:

Article

Safety and Tolerability of the Chymase Inhibitor Fulacimstat in Patients With Left Ventricular Dysfunction After Myocardial Infarction—Results of the CHIARA MIA 1 Trial.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 942, doi. 10.1002/cpdd.633

By:

Düngen, Hans‐Dirk;
Kober, Lars;
Nodari, Savina;
Schou, Morten;
Otto, Christiane;
Becka, Michael;
Kanefendt, Friederike;
Winkelmann, Bernhard R.;
Gislason, Gunnar;
Richard, Frank;
Nielsen, Olav Wendelboe;
Gheorghiade, Mihai;
Senni, Michele

Publication type:

Article

Population Pharmacokinetic Analysis of Daclatasvir, Asunaprevir, and Beclabuvir Combination in HCV‐Infected Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 802, doi. 10.1002/cpdd.649

By:

Osawa, Mayu;
Ueno, Takayo;
Shiozaki, Tomomi;
Ishikawa, Hiroki;
Li, Hanbin;
Garimella, Tushar

Publication type:

Article

No Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 818, doi. 10.1002/cpdd.648

By:

Choi, Taylor;
Komirenko, Allison S.;
Riddle, Valerie;
Kim, Aryun;
Dhuria, Shyeilla V.

Publication type:

Article

Effect of Rifampicin on the Pharmacokinetics of a Single Dose of Vemurafenib in Patients With BRAF<sup>V600</sup> Mutation–Positive Metastatic Malignancy.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 837, doi. 10.1002/cpdd.643

By:

Zhang, Weijiang;
McIntyre, Christine;
Forbes, Harper;
Gaafar, Rabab;
Kohail, Hanaa;
Beck, J. Thaddeus;
Plestina, Stjepko;
Bertran, Enric;
Riehl, Todd

Publication type:

Article

Clinical Pharmacokinetics (ADME).

Published in:: Clinical Pharmacology in Drug Development, 2019, v. 8, p. 1, doi. 10.1002/cpdd.724
Publication type:: Article

Correction to: Pharmacokinetics and Bioavailability of a New Testosterone Gel Formulation in Comparison to Testogel® in Healthy Men.

Published in:: Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 844, doi. 10.1002/cpdd.705
Publication type:: Article

Pharmacokinetic Properties of Ibuprofen (IBU) From the Fixed‐Dose Combination IBU/Caffeine (400/100 mg; FDC) in Comparison With 400 mg IBU as Acid or Lysinate Under Fasted and Fed Conditions—Data From 2 Single‐Center, Single‐Dose, Randomized Crossover Studies in Healthy Volunteers

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 742, doi. 10.1002/cpdd.672

By:

Weiser, Thomas;
Schepers, Cornelia;
Mück, Tobias;
Lange, Robert

Publication type:

Article

Drug‐Drug Interactions of Tacrolimus or Cyclosporine With Glecaprevir and Pibrentasvir in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 779, doi. 10.1002/cpdd.671

By:

Kosloski, Matthew P.;
Zhao, Weihan;
Li, Hong;
Pugatch, David;
Asatryan, Armen;
Kort, Jens;
Mensa, Federico J.;
Liu, Wei

Publication type:

Article

A Randomized, Double‐Blind, Placebo‐Controlled, First‐Time‐in‐Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 790, doi. 10.1002/cpdd.670

By:

Han, Kelong;
Cremer, Jennifer;
Elston, Robert;
Oliver, Stuart;
Baptiste‐Brown, Sharon;
Chen, Shuguang;
Gardiner, David;
Davies, Matt;
Saunders, Joanne;
Hamatake, Robert;
Losos, Jan;
Leivers, Martin;
Hood, Steve;
Berg, Frans;
Paff, Melanie;
Ritter, James M.;
Theodore, Dickens

Publication type:

Article

Randomized Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Topical Daprodustat in Healthy Volunteers and in Patients With Diabetic Foot Ulcers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 765, doi. 10.1002/cpdd.654

By:

Olson, Eric;
Mahar, Kelly M.;
Morgan, Lisa;
Fillmore, Christina;
Holland, Claire;
Lavery, Lawrence

Publication type:

Article

Single‐Dose Pharmacokinetic Properties and Relative Bioavailability of Different Formulations of Posaconazole Oral Suspension in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 827, doi. 10.1002/cpdd.636

By:

Vuletić, Lucija;
Herceg, Marina;
Ferderber, Kristina;
Tunjić, Iva;
Rizea‐Savu, Simona;
Duna, Simona Nicoleta;
Cetina‐Čižmek, Biserka;
Filipović‐Grčić, Jelena

Publication type:

Article

Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 721, doi. 10.1002/cpdd.626

By:

Li, Yan;
Li, Huafang;
Sheng, Yucheng;
Du, Xin;
Yao, Yuhui;
Luo, Xian;
Ma, Peiming

Publication type:

Article

Bioequivalence of Sarpogrelate in Healthy Chinese Subjects Under Fasting and Fed Conditions: A 4‐Way Replicate Crossover Investigation by a Reference‐Scaled Average Bioequivalence Approach.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 713, doi. 10.1002/cpdd.624

By:

Ding, Y.H.;
Liu, B.;
Lou, J.F.;
Sun, J.X.;
Wu, M.;
Zhu, X.X.;
Chen, G.L.;
Zhang, H.;
Li, X.J.;
Chen, H.;
Liu, C.J.;
Shen, Z.W.;
Li, C.Y.

Publication type:

Article

Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 702, doi. 10.1002/cpdd.617

By:

Kotani, Naoki;
Yoneyama, Koichiro;
Kawakami, Nobuhiko;
Shimuta, Tohru;
Fukase, Hiroyuki;
Kawanishi, Takehiko

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2019, v. 8, n. 6, p. 697, doi. 10.1002/cpdd.594
Publication type:: Article

Erratum.

Published in:: 2019
Publication type:: Correction Notice

Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community‐Acquired Pneumonia Treated With Ceftaroline Fosamil.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 5, p. 682, doi. 10.1002/cpdd.673

By:

Li, Jianguo;
Das, Shampa;
Zhou, Diansong;
Al‐Huniti, Nidal

Publication type:

Article

A Phase I Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Adults With Severe Renal Impairment and Healthy Matched Control Participants.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 5, p. 674, doi. 10.1002/cpdd.664

By:

Parasrampuria, Ridhi;
Ford, Susan L.;
Lou, Yu;
Fu, Caifeng;
Bakshi, Kalpana K.;
Tenorio, Allan R.;
Trezza, Christine;
Spreen, William R.;
Patel, Parul

Publication type:

Article

Effects of Food and Antacids on Pharmacokinetics and Pharmacodynamics of Lesinurad, a Selective Urate Reabsorption Inhibitor.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 5, p. 647, doi. 10.1002/cpdd.663

By:

Shen, Zancong;
Lee, Caroline A.;
Valdez, Shakti;
Yang, Xiaojuan;
Wilson, David M.;
Flanagan, Talia;
Gillen, Michael

Publication type:

Article

Lesinurad: Evaluation of Pharmacokinetic and Pharmacodynamic Interactions With Warfarin in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 5, p. 657, doi. 10.1002/cpdd.662

By:

Shen, Zancong;
Lee, Caroline A.;
Wallach, Kathleen;
Valdez, Shakti;
Wilson, David M.;
Kerr, Bradley;
Gillen, Michael

Publication type:

Article

The Relative Bioavailability and Effects of Food and Acid‐Reducing Agents on Filgotinib Tablets in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 5, p. 585, doi. 10.1002/cpdd.659

By:

Anderson, Kacey;
Zheng, Hao;
Kotecha, Mona;
Cuvin, Jennifer;
Scott, Bob;
Sharma, Shringi;
Qin, Ann Ran‐Ran;
Namour, Florence;
Xin, Yan

Publication type:

Article

A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Patients With Hepatic Impairment and Healthy Matched Controls.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 5, p. 664, doi. 10.1002/cpdd.655

By:

Shaik, Jafar Sadik B.;
Ford, Susan L.;
Lou, Yu;
Zhang, Zhiping;
Bakshi, Kalpana K.;
Tenorio, Allan R.;
Trezza, Christine;
Spreen, William R.;
Patel, Parul

Publication type:

Article