Works matching IS 2160763X AND DT 2024 AND VI 13

Results: 154

Relative Bioavailability Studies With Mitapivat: Formulation and Food Effect Assessments in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1271, doi. 10.1002/cpdd.1481

By:

Iyer, Varsha;
Sullivan, Karen;
Yan, Yan;
Hawkins, Peter

Publication type:

Article

A Bioequivalence Study of Azilsartan in Healthy Chinese Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1301, doi. 10.1002/cpdd.1479

By:

Liu, Xiaobei;
Dai, Xiangrong;
Yu, Xiaohui;
Zhou, Huan;
Xie, Jing

Publication type:

Article

Population Pharmacokinetics Modeling and Simulation of Deutenzalutamide, A Novel Androgen Receptor Antagonist, in Patients With Metastatic Castration‐Resistant Prostate Cancer.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1291, doi. 10.1002/cpdd.1477

By:

Liu, Yixian;
He, Yongji;
Qi, Xiaohui;
Li, Xinghai;
Zhou, Yi;
Chen, Yuanwei;
Wang, Zhenlei;
Zheng, Li

Publication type:

Article

Bioequivalence and Pharmacokinetic Evaluation of Regorafenib Tablets in Healthy Chinese Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1317, doi. 10.1002/cpdd.1474

By:

Wang, Zhaoyu;
Zhang, Yun;
Liu, Jingjing;
Chen, Xijing

Publication type:

Article

New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double‐Blind, Parallel‐Group, Single‐Dose Trial in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1308, doi. 10.1002/cpdd.1473

By:

Balser, Sigrid;
Nopora, Katrin;
Körner, Juliane;
Wedemeyer, Ralph‐Steven;
Anschütz, Maria;
Schug, Barbara

Publication type:

Article

Phase 1 Evaluation of the Bioequivalence and Drug‐Drug Interaction Potential of a Novel Fixed‐Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1345, doi. 10.1002/cpdd.1472

By:

Lim, Hyung Soon;
Kim, Jae Hoon;
Hong, Jang Hee;
Jung, Jin‐Gyu;
Sunwoo, Jung

Publication type:

Article

A Bioequivalence Trial of Lenvatinib Mesylate Capsules in Healthy Subjects Under Fasting and Postprandial Conditions.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1324, doi. 10.1002/cpdd.1470

By:

Shao, Junbo;
Liu, Xingxing;
Zhang, Geying;
Xiang, Ajun;
Xie, Xiaoyan

Publication type:

Article

Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1339, doi. 10.1002/cpdd.1467

By:

Hu, Shengling;
Liu, Xia;
Wan, Qinghua;
Zhang, Xueyuan;
Gong, Fengyun

Publication type:

Article

Bioequivalence and Safety of Generic Glecaprevir/Pibrentasvir Compared to a Branded Product: A Randomized, Crossover Study in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1331, doi. 10.1002/cpdd.1463

By:

Noskov, Sergei;
Parulya, Olesya;
Lutskova, Lyudmila;
Arefeva, Anna;
Protsenko, Ekaterina;
Banko, Veniamin;
Radaeva, Kseniia;
Matvienko, Iuliia;
Gefen, Maria;
Karnakova, Polina;
Knyazeva, Alina;
Komarov, Timofey;
Archakova, Olga;
Shohin, Igor

Publication type:

Article

Effect of Itraconazole, a CYP3A4 Inhibitor, and Rifampin, a CYP3A4 Inducer, on the Pharmacokinetics of Vatiquinone.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1283, doi. 10.1002/cpdd.1461

By:

Lee, Lucy;
Thoolen, Martin;
Ma, Jiyuan;
Kaushik, Diksha;
Golden, Lee;
Kong, Ronald

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2024, v. 13, n. 12, p. 1267, doi. 10.1002/cpdd.1125
Publication type:: Article

Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Recombinant Neorudin, a New Anticoagulant Drug in Patients With Acute Coronary Syndrome.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1189, doi. 10.1002/cpdd.1478

By:

Liu, Yu‐bin;
Liang, Yan;
Liu, Hui‐chen;
Feng, Guang‐xun;
Zhou, Xing‐chen;
Zhang, Lin;
Zhang, Xiao‐long;
Li, Qiang;
Ren, Bo‐yuan;
Xia, Xia;
Zhu, Jun;
Wu, Chu‐tse;
Jin, Ji‐de

Publication type:

Article

Lack of Concentration‐QTc Relationship and Cardiac Risk With Vatiquinone Therapeutic and Supratherapeutic Doses.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1227, doi. 10.1002/cpdd.1476

By:

Lee, Lucy;
Flach, Stephen;
Xue, Hongqi;
Arivelu, Lavanya;
Golden, Lee;
Kong, Ronald;
Darpo, Borje

Publication type:

Article

Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1198, doi. 10.1002/cpdd.1469

By:

Erb‐Zohar, Katharina;
Bonsmann, Susanne;
Pausch, Jörg;
Sumner, Melanie;
Birkmann, Alexander;
Zimmermann, Holger;
Halabi, Atef;
Kropeit, Dirk

Publication type:

Article

Pharmacokinetics of Subcutaneous Itepekimab Injection With an Autoinjector Device and Prefilled Syringe in Healthy Participants.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1181, doi. 10.1002/cpdd.1466

By:

Xu, Christine;
Xin, Kong;
Kosloski, Matthew P.;
Butler, Allison;
Goulaouic, Helene;
Nivens, Michael C.;
Kanamaluru, Vanaja

Publication type:

Article

Pharmacokinetics and Safety of Linezolid Tablets of 2 Different Manufacturers in Healthy Chinese Subjects in Fasting and Fed States.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1239, doi. 10.1002/cpdd.1462

By:

Chen, Hanjing;
Xu, Hongrong;
Yuan, Fei;
Li, Hui;
Sheng, Lei;
Liu, Chao;
Chen, Weili;
Li, Xuening

Publication type:

Article

Comparative Bioavailability of a Novel Fixed‐dose Combination Etoricoxib and Tramadol.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1253, doi. 10.1002/cpdd.1456

By:

Garza‐Ocañas, Lourdes;
Badillo‐Castaneda, Christian T.;
Eguía, Sandra L. Montoya;
Zanatta‐Calderón, María T.;
Garza, Julia D. Torres;
Gómez‐Meza, Marco Vinicio;
Sander‐Padilla, José G.;
Lugo‐Sánchez, Laura A.;
Rios‐Brito, Kevin F.;
Romero‐Antonio, Yulia;
González‐Canudas, Jorge

Publication type:

Article

Bioequivalence and Food Effect Assessment of Eltrombopag Olamine Tablets in Healthy Chinese Subjects: An Open, Randomized, Single‐Dose, and Two‐Period Crossover Study.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1260, doi. 10.1002/cpdd.1453

By:

Wang, Jingyan;
Zhao, Zhicheng;
Tao, Ye;
Lan, Yi

Publication type:

Article

Impact of a High‐Fat Meal on the Pharmacokinetics of Sotorasib, a KRAS G12C Inhibitor.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1219, doi. 10.1002/cpdd.1452

By:

Cardona, Panli;
Dutta, Sandeep;
Houk, Brett

Publication type:

Article

Effect of a High‐Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1212, doi. 10.1002/cpdd.1451

By:

Boinpally, Ramesh R.;
Trugman, Joel M.

Publication type:

Article

Pharmacokinetic Profile and Comparative Bioavailability of an Oral Fixed‐Dose Combination of Metformin and Acetylsalicylic Acid (Aspirin).

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1245, doi. 10.1002/cpdd.1450

By:

Garza‐Ocañas, Lourdes;
Badillo‐Castañeda, Christian T.;
Montoya‐Eguía, Sandra L.;
Zanatta‐Calderón, Maria T.;
Sáenz‐Chávez, Pedro Lennon;
Torres‐Garza, Julia D.;
Rodriguez‐Vazquez, Ileana C.;
Romero‐Antonio, Yulia;
Rios‐Brito, Kevin F.;
González‐Canudas, Jorge

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2024, v. 13, n. 11, p. 1177, doi. 10.1002/cpdd.1124
Publication type:: Article

Meta‐Analysis of Noncompartmental Pharmacokinetic Parameters to Evaluate the Impact of CYP2C19 and CYP2C9 Genetic Polymorphisms on Abrocitinib Exposure.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1098, doi. 10.1002/cpdd.1465

By:

Fostvedt, Luke;
Liu, Jian;
Wang, Xiaoxing;
Li, Yinhua;
Johnson, Jillian;
Wood, Linda;
Dowty, Martin;
Malhotra, Bimal;
Valdez, Hernan;
Nicholas, Timothy;
Xue, Wei

Publication type:

Article

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Muscarinic M<sub>3</sub> Receptor‐Positive Allosteric Modulator ASP8302 Following Single and Multiple Ascending Oral Doses in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1130, doi. 10.1002/cpdd.1460

By:

Takusagawa, Shin;
Treijtel, Nicoline;
Saito, Masako;
Michon, Ingrid;
Miyatake, Daisuke;
Osaki, Fumio;
Guro, Sayuri;
Fadini, Tomasso;
Sekino, Hisakuni;
Aarden‐Bakker, Marlous;
Kuroishi, Kentaro;
van Till, Jan Willem Olivier;
Groenendaal‐van de Meent, Dorien;
de Vries, Michiel

Publication type:

Article

Absorption, Metabolism, and Excretion of [<sup>14</sup>C]‐Labeled Anaprazole: A New Proton Pump Inhibitor, After a Single Oral Administration in Healthy Chinese Male Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1115, doi. 10.1002/cpdd.1458

By:

Xie, Lijun;
Xu, Yanjun;
Liu, Wei;
Zhou, Chen;
Guo, Lian;
Zhou, Sufeng;
Zhang, Chen;
Chen, Juan;
Zhu, Bei;
Ding, Sijia;
Li, Huan;
Zhang, Lingling;
Wang, Li;
Xu, Lingmei;
Shao, Feng;
Wang, Lu

Publication type:

Article

Pharmacokinetic and Bioequivalence Evaluation of Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate, and Aspirin Tablets in Healthy Chinese Subjects in the Fasting and Postprandial Conditions.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1157, doi. 10.1002/cpdd.1455

By:

Yao, Fang;
He, Yingxia;
Lu, Pan;
Wang, Jie;
Xie, Yafang;
Li, Xiuwen;
Liu, Qiangwei;
Liu, Yang;
Cao, Dan;
Liang, Jun;
Liu, Guan

Publication type:

Article

A Phase 1, Single‐Dose Study to Evaluate the Pharmacokinetics and Safety of Bepirovirsen in Adults with Hepatic Impairment and Healthy Participants (B‐Assured).

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1088, doi. 10.1002/cpdd.1454

By:

Noormohamed, Nadia;
Lukic, Tamara;
Marbury, Thomas C.;
Lawitz, Eric J.;
Prescott, Holly;
Magee, Mindy;
Nader, Ahmed;
Han, Kelong

Publication type:

Article

Safety and Pharmacokinetics of Single‐Dose Mirikizumab in Chinese Healthy Participants: Results From a Phase 1 Study.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1143, doi. 10.1002/cpdd.1449

By:

Xu, Junyu;
Xie, Ran;
Ji, Yongjia;
Qian, Chenxi;
Zhang, Xin;
Todd, Kris;
Wang, Feng;
Cui, Yimin

Publication type:

Article

Effect of Erdafitinib on the Pharmacokinetics of Midazolam and Metformin in Patients With Advanced Solid Tumors Harboring FGFR Gene Alterations.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1164, doi. 10.1002/cpdd.1445

By:

Zhu, Wei;
Baig, Mahadi;
Naini, Vahid;
De Meulder, Marc;
Akapame, Sydney;
De Zwart, Loeckie;
Haddish‐Berhane, Nahor;
Triantos, Spyros

Publication type:

Article

Bioequivalence of Recombinant Human Teriparatide Injection in Healthy Adult Female Subjects in the Fasting State.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1151, doi. 10.1002/cpdd.1440

By:

Hu, Shengling;
Wen, Yalei;
Li, Jing;
Chen, Wenming;
Bai, Yichuan;
Gong, Fengyun

Publication type:

Article

Bioequivalence Study of Velpatasvir/Sofosbuvir Oral Coated Tablets in Healthy Volunteers Under Fasting Conditions.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1123, doi. 10.1002/cpdd.1435

By:

Noskov, Sergei;
Arefeva, Anna;
Radaeva, Kseniia;
Makarenko, Igor;
Gefen, Maria;
Drai, Roman

Publication type:

Article

A Randomized, Cross‐Over Study Investigating the Comparability of Somatrogon‐ghla in 2 Different Drug Product Presentations.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1108, doi. 10.1002/cpdd.1434

By:

Manners, Allison;
Korth‐Bradley, Joan;
Wajnrajch, Michael P.

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2024, v. 13, n. 10, p. 1083, doi. 10.1002/cpdd.1123
Publication type:: Article

2024 CPDD Abstract Booklet.

Published in:: Clinical Pharmacology in Drug Development, 2024, v. 13, p. 1, doi. 10.1002/cpdd.1459
Publication type:: Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2024, v. 13, p. i, doi. 10.1002/cpdd.1128
Publication type:: Article

Consideration of the Root Causes in Candidate Attrition During Oncology Drug Development.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 952, doi. 10.1002/cpdd.1464

By:

Kuo, Yin‐Ming;
Barrett, Jeffrey S.

Publication type:

Article

Population Pharmacokinetics of Naloxegol in Pediatric Subjects Receiving Opioids.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 974, doi. 10.1002/cpdd.1457

By:

Hruska, Matthew W.;
Mascelli, Mary Ann;
Liao, Sam;
Liao, Lori;
Davies, Patrick;
Kong, Jennifer;
Marsteller, Douglas A.

Publication type:

Article

The Bioequivalence of Abexinostat (CRA‐024781) Tosylate Tablets (20 mg) in Chinese Healthy Subjects Under Fasting Conditions.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1061, doi. 10.1002/cpdd.1448

By:

Li, Xiang;
Guo, Wenqiang;
Chen, Jian;
Tan, Gewen

Publication type:

Article

Clinical Implications of Co‐administering Apixaban with Key Interacting Medications.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 961, doi. 10.1002/cpdd.1446

By:

Favatella, Nicholas;
Dalton, David;
Byon, Wonkyung;
Merali, Samira J.;
Klem, Christian

Publication type:

Article

Effect of Mild or Moderate Hepatic Impairment on the Pharmacokinetics of Avacopan, a Small‐Molecule Complement C5a Receptor Antagonist, for the Treatment of Antineutrophil Cytoplasmic Autoantibody‐Associated Vasculitis.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1000, doi. 10.1002/cpdd.1444

By:

Miao, Shichang;
Suso, Pablo;
Furst, John A.;
Hudson, Matthew G.;
Trivedi, Ashit

Publication type:

Article

Food Effect and Pharmacokinetic Bridging of Avacopan in Caucasian and Japanese Healthy Participants.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1011, doi. 10.1002/cpdd.1436

By:

Miao, Shichang;
Bekker, Pirow;
Armas, Danielle;
Lor, Mary;
Hanada, Ryuzo;
Okamura, Shota;
Umezawa, Yuko;
Trivedi, Ashit

Publication type:

Article

Comparative Bioequivalence Study of 2 Clopidogrel 75‐mg Tablet Formulations in Moroccan Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1044, doi. 10.1002/cpdd.1442

By:

Orche, Aimen El;
Khabbaz, Choukri El;
Cheikh, Amine;
Bouchafra, Houda;
Jawhari, Samira;
Abbes, Faouzi My El;
Cherrah, Yahya

Publication type:

Article

A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled, Single Ascending Dose Trial of AWZ1066S, an Anti‐Wolbachia Candidate Macrofilaricide.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1071, doi. 10.1002/cpdd.1441

By:

Devereux, Graham;
Bula, Marcin;
Tripp, Karen;
Fitzgerald, Richard;
Eraut, Nicola;
Alam, Muhammad Salman;
Moriyama, Tomoyuki;
Shinkyo, Raku;
Walker, Lauren;
Wang, Duolao;
Gusovsky, Fabian;
van der Velde, Jeannette;
Turner, Joseph D.;
Hong, Weiqian David;
O'Neill, Paul M.;
Taylor, Mark J.;
Ward, Stephen A.

Publication type:

Article

SERENE ER Analysis Part 1‐SERENE CD: Exposure‐Response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients With Moderately to Severely Active Crohn Disease.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1024, doi. 10.1002/cpdd.1438

By:

Chen, Mong‐Jen;
Ponce‐Bobadilla, Ana Victoria;
Stodtmann, Sven;
Song, Alexandra P.;
Finney‐Hayward, Tricia K.;
Mostafa, Nael M.

Publication type:

Article

SERENE ER Analysis Part 2 SERENE‐UC: Exposure‐response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients with Moderately to Severely Active Ulcerative Colitis.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1033, doi. 10.1002/cpdd.1437

By:

Stodtmann, Sven;
Chen, Mong‐Jen;
Ponce‐Bobadilla, Ana Victoria;
Finney‐Hayward, Tricia K.;
Kalabic, Jasmina;
Mostafa, Nael M.

Publication type:

Article

Safety and Pharmacokinetics of a Combined Antioxidant Therapy against Myocardial Reperfusion Injury: A Phase 1 Randomized Clinical Trial in Healthy Humans.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 1051, doi. 10.1002/cpdd.1443

By:

Gajardo Cortez, Abraham I.J.;
Lillo‐Moya, José;
San‐Martín‐Martinez, Daniel;
Pozo‐Martinez, Josue;
Morales, Pablo;
Prieto, Juan C.;
Aguayo, Rubén;
Puentes, Ángel;
Ramos, Cristobal;
Silva, Solange;
Catalán, Mabel;
Ramos, Karla;
Olea‐Azar, Claudio;
Rodrigo, Ramón

Publication type:

Article

Enhanced Bioavailability and Reduced Variability of Dasatinib and Sorafenib with a Novel Amorphous Solid Dispersion Technology Platform.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 985, doi. 10.1002/cpdd.1416

By:

Lennernäs, Hans;
Brisander, Magnus;
Liljebris, Charlotta;
Jesson, Gérald;
Andersson, Per

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2024, v. 13, n. 9, p. 947, doi. 10.1002/cpdd.1122
Publication type:: Article

Population Pharmacokinetics and Exposure‐Response Relationship of Zimberelimab in Chinese Patients with Advanced Tumors.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 8, p. 897, doi. 10.1002/cpdd.1439

By:

Yang, Fang;
Lu, Yongying;
Bai, Lihui;
Deng, Chenhui;
Liu, Zhen;
Sun, Zhihua;
Li, Li;
Wang, Shicong;
Zhou, Li;
Feng, Haifeng;
Yan, Shaoyu;
Zhu, Jiman

Publication type:

Article

Impact of Food on the Oral Absorption of N‐Acetyl‐D‐Mannosamine in Healthy Men and Women.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 8, p. 876, doi. 10.1002/cpdd.1433

By:

Evans, Allan M.;
Fornasini, Gianfranco;
Meola, Tahlia R.;
Gahl, William A.;
Huizing, Marjan;
Polasek, Thomas M.;
Reuter, Stephanie E.

Publication type:

Article