Works matching IS 2160763X AND DT 2020 AND VI 9

Results: 111

Safety, Tolerability, Pharmacokinetics, and Food Effects on TAC‐302 in Healthy Participants: Randomized, Double‐Blind, Placebo‐Controlled, Single‐Dose and Multiple‐Dose Studies.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 821, doi. 10.1002/cpdd.776

By:

Sesoko, Shogo;
Huang, Jinhong;
Okayama, Takashige;
Nishida, Erika;
Miyoshi, Kazuhisa

Publication type:

Article

Levocetirizine Oral Disintegrating Tablet: A Randomized Open‐Label Crossover Bioequivalence Study in Healthy Japanese Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 805, doi. 10.1002/cpdd.791

By:

Ino, Hiroko;
Shiramoto, Masanari;
Eto, Takashi;
Haranaka, Miwa;
Irie, Shin;
Terao, Takumi;
Ogura, Hirofumi;
Wakamatsu, Akira;
Hoyano, Keiko;
Nakano, Atsushi

Publication type:

Article

The Bioequivalence of Tafamidis 61‐mg Free Acid Capsules and Tafamidis Meglumine 4 × 20‐mg Capsules in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 849, doi. 10.1002/cpdd.789

By:

Lockwood, Peter A.;
Le, Vu H.;
O'Gorman, Melissa T.;
Patterson, Terrell A.;
Sultan, Marla B.;
Tankisheva, Ekaterina;
Wang, Qiang;
Riley, Steve

Publication type:

Article

A Phase 1, Randomized, Placebo‐Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 833, doi. 10.1002/cpdd.775

By:

Sakamoto, Kei;
Matsuki, Shunji;
Irie, Shin;
Uchida, Naoki;
Hayashi, Nobuya;
Horiuchi, Masato;
Ren, Song

Publication type:

Article

Platelet Function: Meloxicam Intravenous in Whole Blood Samples From Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 841, doi. 10.1002/cpdd.772

By:

Jahr, Jonathan S.;
Searle, Shawn;
McCallum, Stewart;
Mack, Randall;
Minger, Kim;
Freyer, Alex;
Du, Wei;
Hobson, Sue

Publication type:

Article

A Review on Drug‐Induced Nephrotoxicity: Pathophysiological Mechanisms, Drug Classes, Clinical Management, and Recent Advances in Mathematical Modeling and Simulation Approaches.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 896, doi. 10.1002/cpdd.879

By:

Mody, Hardik;
Ramakrishnan, Vidya;
Chaar, Maher;
Lezeau, Jovin;
Rump, Adrian;
Taha, Kareem;
Lesko, Lawrence;
Ait‐Oudhia, Sihem

Publication type:

Article

Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 952, doi. 10.1002/cpdd.868

By:

Zhao, Xia;
Sheng, Xiao Yan;
Payne, Christopher D.;
Zhang, Xin;
Wang, Feng;
Cui, Yi Min

Publication type:

Article

Bioequivalence and Pharmacokinetic Evaluation of Two Metformin Hydrochloride Tablets Under Fasting and Fed Conditions in Healthy Chinese Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 910, doi. 10.1002/cpdd.849

By:

Huang, Xiao‐mei;
Wang, Gong‐zhu;
He, Bin‐bin;
Gao, Ting;
Long, Ping;
Zhang, Bi‐kui

Publication type:

Article

A Randomized, Double‐Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 1003, doi. 10.1002/cpdd.845

By:

Burmester, Gerd;
Chien, David;
Chow, Vincent;
Gessner, Melissa;
Pan, Jean;
Cohen, Stanley

Publication type:

Article

Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 918, doi. 10.1002/cpdd.842

By:

Tammara, Brinda K.;
Ryan, Kelly;
Plotka, Anna;
Shafer, Frank E.;
Wei, Hua;
Readett, David;
Fang, Annie;
Korth‐Bradley, Joan M.

Publication type:

Article

A Phase 1 Study to Assess the Relative Bioavailability, Food Effect, and Safety of a Tablet Formulation of GSK2838232, a Novel HIV Maturation Inhibitor in Healthy Participants After Single and Repeated Doses.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 972, doi. 10.1002/cpdd.820

By:

Johnson, Mark;
Jewell, Roxanne C.;
Gan, Jianjun;
Dumont, Etienne;
Burns, Olivia;
Johns, Brian A.

Publication type:

Article

Effects of Multiple‐Dose Administration of Aprocitentan on the Pharmacokinetics of Rosuvastatin.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 995, doi. 10.1002/cpdd.815

By:

Sidharta, Patricia N.;
Dingemanse, Jasper

Publication type:

Article

Safety and Pharmacokinetics of High‐Dose TAS‐303 in Healthy Japanese Volunteers: A Single‐Center, Single‐Blind, Randomized, Placebo‐Controlled, Parallel‐Group, Multiple‐Ascending‐Dose Study.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 961, doi. 10.1002/cpdd.801

By:

Hanada, Ryuzo

Publication type:

Article

Pharmacokinetics of Single and Multiple Doses of Omega‐3 Carboxylic Acids in Healthy Chinese Subjects: A Phase I, Open‐Label Study.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 985, doi. 10.1002/cpdd.800

By:

Jing, Shan;
Zhang, Zhenxian;
Chen, Xiaowen;
Miao, Rui;
Nilsson, Catarina;
Lin, Yang

Publication type:

Article

A Single‐Dose, Open‐Label, Randomized, Two‐Way Crossover Study in Healthy Japanese Participants to Evaluate the Bioequivalence and the Food Effect on the Pharmacokinetics of Daprodustat.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 978, doi. 10.1002/cpdd.793

By:

Yamada, Masanori;
Osamura, Minori;
Ogura, Hirofumi;
Onoue, Tomohiro;
Wakamatsu, Akira;
Numachi, Yotaro;
Caltabiano, Stephen;
Mahar, Kelly M.

Publication type:

Article

The Effect of CYP3A Induction and Inhibition on the Pharmacokinetics of Laquinimod, a Novel Neuroimmunomodulator.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 1015, doi. 10.1002/cpdd.785

By:

Elgart, Anna;
Greenblatt, David J.;
Loupe, Pippa S.;
Zur, Arik A.;
Weiss, Sivan;
Mimrod, Dorit;
Spiegelstein, Ofer

Publication type:

Article

Thorough QT/QTc Study Shows That a Novel 5‐HT4 Receptor Partial Agonist Minesapride Has No Effect on QT Prolongation.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 938, doi. 10.1002/cpdd.778

By:

Hamatani, Tatsuto;
Noda, Naoto;
Takagaki, Takeshi;
Yodo, Yasuhide;
Kawai, Hirotaka;
Kakuyama, Hiroyoshi;
Kaji, Yoshikazu;
Fujio, Yasushi

Publication type:

Article

Pilot Study to Predict Pharmacokinetics of a Therapeutic Gemcitabine Dose From a Microdose.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 929, doi. 10.1002/cpdd.774

By:

Van Nuland, M.;
Rosing, H.;
Thijssen, B.;
Burgers, J.A.;
Huitema, A.D.R.;
Marchetti, S.;
Schellens, J.H.M.;
Beijnen, J.H.

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, n. 8, p. 891, doi. 10.1002/cpdd.682
Publication type:: Article

Correction.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 889, doi. 10.1002/cpdd.861
Publication type:: Article

Pharmacokinetics and Bioequivalence Estimation of Two Formulations of Alfuzosin Extended‐Release Tablets.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 780, doi. 10.1002/cpdd.860

By:

Al Bawab, Abdel Qader;
Alkhalidi, Bashar A.;
Albarahmieh, Esra'a;
Qassim, Sami M.A.;
Al‐Saifi, Mohammad A.D.;
Al‐Saifi, Bashar;
Ling, Jonathan;
Al‐Qerem, Walid

Publication type:

Article

Evaluation of Absolute Oral Bioavailability and Bioequivalence of Ribociclib, a Cyclin‐Dependent Kinase 4/6 Inhibitor, in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 855, doi. 10.1002/cpdd.853

By:

Ji, Yan;
Abdelhady, Ahmed M.;
Samant, Tanay S.;
Yang, Shu;
Rodriguez Lorenc, Karen

Publication type:

Article

Application of a Backpropagation Artificial Neural Network in Predicting Plasma Concentration and Pharmacokinetic Parameters of Oral Single‐Dose Rosuvastatin in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 867, doi. 10.1002/cpdd.809

By:

Xu, Yichao;
Lou, Honggang;
Chen, Jinliang;
Jiang, Bo;
Yang, Dandan;
Hu, Yin;
Ruan, Zourong

Publication type:

Article

Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 876, doi. 10.1002/cpdd.808

By:

Patel, Chirag;
Goel, Sanjay;
Patel, Manish R.;
Rangachari, Lakshmi;
Wilbur, Jayson D.;
Shou, Yaping;
Venkatakrishnan, Karthik;
Lockhart, A. Craig

Publication type:

Article

Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open‐Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 813, doi. 10.1002/cpdd.804

By:

Pei, Tong;
Yang, Jing;
Hu, Chaoying;
Chen, Xiaoping;
Gong, Shili;
Hu, Xiao;
Li, Lin;
Zhang, Lan

Publication type:

Article

Single‐Dose Pharmacokinetics, Safety, and Tolerability of Avadomide (CC‐122) in Subjects With Mild, Moderate, or Severe Renal Impairment.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 785, doi. 10.1002/cpdd.760

By:

Li, Yan;
MacGorman, Kimberly;
Liu, Liangang;
Chen, Jian;
Hoffmann, Matthew;
Palmisano, Maria;
Zhou, Simon

Publication type:

Article

The Effect of Food on the Single‐Dose Bioavailability and Tolerability of the Highest Marketed Strength of Duloxetine.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 797, doi. 10.1002/cpdd.759

By:

Rizea‐Savu, Simona;
Duna, Simona Nicoleta;
Ghita, Adrian;
Iordachescu, Adriana;
Chirila, Marinela

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, n. 7, p. 775, doi. 10.1002/cpdd.681
Publication type:: Article

ACCP Abstract Booklet.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, p. 1, doi. 10.1002/cpdd.858
Publication type:: Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, p. i, doi. 10.1002/cpdd.675
Publication type:: Article

Correction.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 774, doi. 10.1002/cpdd.854
Publication type:: Article

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 742, doi. 10.1002/cpdd.798

By:

Li, Zhaoyang;
Radin, Allen;
Li, Meng;
Hamilton, Jennifer D.;
Kajiwara, Miyuki;
Davis, John D.;
Takahashi, Yoshinori;
Hasegawa, Setsuo;
Ming, Jeffrey E.;
DiCioccio, A. Thomas;
Li, Yongtao;
Kovalenko, Pavel;
Lu, Qiang;
Ortemann‐Renon, Catherine;
Ardeleanu, Marius;
Swanson, Brian N.

Publication type:

Article

Randomized, Double‐Blind, Single‐Dose, Placebo‐Controlled Crossover Study to Evaluate the Effects of Esaxerenone on QTc Interval in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 709, doi. 10.1002/cpdd.794

By:

Mendell, Jeanne;
Kobayashi, Fumiaki;
Shimizu, Takako

Publication type:

Article

Modeling and Simulation of the Pharmacokinetics and Target Engagement of an Antagonist Monoclonal Antibody to Interferon‐γ–Induced Protein 10, BMS‐986184, in Healthy Participants to Guide Therapeutic Dosing.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 689, doi. 10.1002/cpdd.784

By:

Cai, Weiguo;
Leil, Tarek A.;
Gibiansky, Leonid;
Krishna, Murli;
Zhang, Hongwei;
Gu, Huidong;
Sun, Huadong;
Throup, John;
Banerjee, Subhashis;
Girgis, Ihab

Publication type:

Article

Base and Covariate Population Pharmacokinetic Analyses of Dupilumab Using Phase 3 Data.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 756, doi. 10.1002/cpdd.780

By:

Kovalenko, Pavel;
Davis, John D.;
Li, Meng;
Rippley, Ronda;
Ardeleanu, Marius;
Shumel, Brad;
Graham, Neil M.H.;
Pirozzi, Gianluca;
Kamal, Mohamed A.;
DiCioccio, A. Thomas

Publication type:

Article

Evaluation of the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Pyrimethamine in Healthy Male Subjects of Japanese and European Ancestry.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 768, doi. 10.1002/cpdd.771

By:

Iida, Takayuki;
Nand, Romina A.;
Ino, Hiroko;
Ogura, Hirofumi;
Itoh, Hiroshi;
Igarashi, Harue;
Numachi, Yotaro;
Gross, Annette S.

Publication type:

Article

Evaluation of Pharmacokinetics and Dose Proportionality of Diazepam After Intranasal Administration of NRL‐1 to Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 719, doi. 10.1002/cpdd.767

By:

Tanimoto, Sarina;
Pesco Koplowitz, Luana;
Lowenthal, Richard E.;
Koplowitz, Barry;
Rabinowicz, Adrian L.;
Carrazana, Enrique

Publication type:

Article

Evaluation of Clinical Cardiac Safety of Itacitinib, a JAK1 Inhibitor, in Healthy Participants.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 677, doi. 10.1002/cpdd.758

By:

Gong, Xiaohua;
Darpo, Borje;
Xue, Hongqi;
Punwani, Naresh;
He, Kevin;
Barbour, April M.;
Epstein, Noam;
Landman, Robert;
Chen, Xuejun;
Yeleswaram, Swamy

Publication type:

Article

Pharmacokinetics, Bioequivalence, and Safety Studies of Prucalopride in Healthy Chinese Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 671, doi. 10.1002/cpdd.754

By:

Zhou, Ziye;
Wang, Chenxiang;
Zheng, Xuyong;
Yu, Xuben;
Yu, Chao;
Zhang, Dongchuan;
Xia, Yan;
Chen, Huafang;
Huang, Xiaoxiao;
Zhang, Xiuhua

Publication type:

Article

Pharmacokinetic Analysis of Weekly Versus Biweekly IgPro20 Dosing in Patients With Primary Immunodeficiency.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 664, doi. 10.1002/cpdd.753

By:

Rojavin, Mikhail A.;
Chapdelaine, Hugo;
Tortorici, Michael A.;
Praus, Michaela;
Baheti, Gautam;
Zhang, Ying;
Hofmann, Jutta;
Labrosse, Roxane;
Dicaire, Renée;
Haddad, Elie

Publication type:

Article

A Mass Balance Study of 14C‐Labeled JTZ‐951 (Enarodustat), a Novel Orally Available Erythropoiesis‐Stimulating Agent, in Patients With End‐Stage Renal Disease on Hemodialysis.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 728, doi. 10.1002/cpdd.752

By:

Pai, Sudhakar M.;
Connaire, Jeffrey;
Yamada, Hiroyuki;
Enya, Seiji;
Gerhardt, Barbara;
Maekawa, Michihide;
Tanaka, Hiromasa;
Koretomo, Ryosuke;
Ishikawa, Tomohiro

Publication type:

Article

Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects With Normal and Impaired Hepatic Function.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 699, doi. 10.1002/cpdd.751

By:

Miyatake, Daisuke;
Shibata, Tomohisa;
Toyoshima, Junko;
Kaneko, Yuichiro;
Oda, Kazuo;
Nishimura, Tetsuya;
Katashima, Masataka;
Sakaki, Masashi;
Inoue, Kazuaki;
Ito, Takayoshi;
Uchida, Naoki;
Furihata, Kenichi;
Urae, Akinori

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 659, doi. 10.1002/cpdd.680
Publication type:: Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2020, v. 9, p. S1, doi. 10.1002/cpdd.859
Publication type:: Article

Parameter Estimation and Reporting in Noncompartmental Analysis of Clinical Pharmacokinetic Data.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, p. S5, doi. 10.1002/cpdd.810

By:

Noe, Dennis A.

Publication type:

Article

Stable Isotopically Labeled Intravenous Microdose Pharmacokinetic Trials as a Tool to Assess Absolute Bioavailability: Feasibility and Paradigm to Apply for Protein Kinase Inhibitors in Oncology.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 5, p. 552, doi. 10.1002/cpdd.840

By:

Roosendaal, Jeroen;
Rosing, Hilde;
Beijnen, Jos H.

Publication type:

Article

Bioequivalence Study of 2 Capsule Formulations of Fingolimod 0.5 mg Assessing Both Parent Drug and Active Metabolite in New Zealand Healthy Subjects (Truncated Design).

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 5, p. 610, doi. 10.1002/cpdd.813

By:

Hung, Noelyn Anne;
Costa, Fernando Guillermo;
Hung, Cheung‐Tak;
Rosenberg, Mónica Esther

Publication type:

Article

Pharmacokinetics of Gepotidacin in Renal Impairment.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 5, p. 560, doi. 10.1002/cpdd.807

By:

Hossain, Mohammad;
Tiffany, Courtney;
Raychaudhuri, Aparna;
Nguyen, Dung;
Tai, Guoying;
Alcorn, Harry;
Preston, Richard A.;
Marbury, Thomas;
Dumont, Etienne

Publication type:

Article

Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 5, p. 573, doi. 10.1002/cpdd.806

By:

Lv, Yuan;
Luo, Bin‐yu;
LaBadie, Robert R.;
Zhu, Hua;
Feng, Yan;
Ernst, Cynthia;
Crownover, Penelope H.;
Liang, Yali;
Zhao, Qinying

Publication type:

Article

Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine (a CYP1A2 Substrate) in Patients With BRAFV600 Mutation–Positive Malignancies.

Published in:

Clinical Pharmacology in Drug Development, 2020, v. 9, n. 5, p. 651, doi. 10.1002/cpdd.788

By:

Zhang, Weijiang;
McIntyre, Christine;
Riehl, Todd;
Forbes, Harper;
Bertran, Enric;
Choi, Hye Jin;
Lee, Dae Ho;
Lee, Jeeyun

Publication type:

Article