Pharmacokinetics, Pharmacodynamics, and Safety Evaluation of the Novel HIF-PH Inhibitor Enarodustat: An Open-Label Phase I Study in Healthy Chinese Participants.

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Title: Pharmacokinetics, Pharmacodynamics, and Safety Evaluation of the Novel HIF-PH Inhibitor Enarodustat: An Open-Label Phase I Study in Healthy Chinese Participants.
Authors: Cui C; Department of Cardiology, Peking University Third Hospital, Beijing, 100191, China.; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China., Niu X; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China., Li H; Department of Cardiology, Peking University Third Hospital, Beijing, 100191, China.; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China., Zhang R; Department of Clinical Pharmacology, Shenzhen Salubris Pharmaceuticals Co. Ltd, Beijing, 100022, China., Geng L; Department of Clinical Pharmacology, Shenzhen Salubris Pharmaceuticals Co. Ltd, Beijing, 100022, China., Lin W; Department of Clinical Operations, Shenzhen Salubris Pharmaceuticals Co. Ltd, Shenzhen, 518000, China., Liu Z; Department of Data Science, Shenzhen Salubris Pharmaceuticals Co. Ltd, Beijing, 100022, China., Wang X; Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China. sshwang@126.com., Liu D; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China. liudongyang@vip.sina.com.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China. liudongyang@vip.sina.com.; Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third Hospital, Beijing, 100191, China. liudongyang@vip.sina.com.
Source: Clinical drug investigation [Clin Drug Investig] 2025 Apr; Vol. 45 (4), pp. 179-189. Date of Electronic Publication: 2025 Mar 13.
Publication Type: Journal Article; Clinical Trial, Phase I
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9504817 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1918 (Electronic) Linking ISSN: 11732563 NLM ISO Abbreviation: Clin Drug Investig Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Pharmacokinetics, Pharmacodynamics, and Safety Evaluation of the Novel HIF-PH Inhibitor Enarodustat: An Open-Label Phase I Study in Healthy Chinese Participants.
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  Data: <searchLink fieldCode="AU" term="%22Cui+C%22">Cui C</searchLink>; Department of Cardiology, Peking University Third Hospital, Beijing, 100191, China.; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China.<br /><searchLink fieldCode="AU" term="%22Niu+X%22">Niu X</searchLink>; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China.<br /><searchLink fieldCode="AU" term="%22Li+H%22">Li H</searchLink>; Department of Cardiology, Peking University Third Hospital, Beijing, 100191, China.; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China.<br /><searchLink fieldCode="AU" term="%22Zhang+R%22">Zhang R</searchLink>; Department of Clinical Pharmacology, Shenzhen Salubris Pharmaceuticals Co. Ltd, Beijing, 100022, China.<br /><searchLink fieldCode="AU" term="%22Geng+L%22">Geng L</searchLink>; Department of Clinical Pharmacology, Shenzhen Salubris Pharmaceuticals Co. Ltd, Beijing, 100022, China.<br /><searchLink fieldCode="AU" term="%22Lin+W%22">Lin W</searchLink>; Department of Clinical Operations, Shenzhen Salubris Pharmaceuticals Co. Ltd, Shenzhen, 518000, China.<br /><searchLink fieldCode="AU" term="%22Liu+Z%22">Liu Z</searchLink>; Department of Data Science, Shenzhen Salubris Pharmaceuticals Co. Ltd, Beijing, 100022, China.<br /><searchLink fieldCode="AU" term="%22Wang+X%22">Wang X</searchLink>; Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China. sshwang@126.com.<br /><searchLink fieldCode="AU" term="%22Liu+D%22">Liu D</searchLink>; Drug Clinical Trial Centre, Peking University Third Hospital, Beijing, 100191, China. liudongyang@vip.sina.com.; Centre of Clinical Medical Research, Institute of Medical Innovation and Research, Peking University Third Hospital, Beijing, 100191, China. liudongyang@vip.sina.com.; Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third Hospital, Beijing, 100191, China. liudongyang@vip.sina.com.
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  Data: <searchLink fieldCode="JN" term="%229504817%22">Clinical drug investigation</searchLink> [Clin Drug Investig] 2025 Apr; Vol. 45 (4), pp. 179-189. <i>Date of Electronic Publication: </i>2025 Mar 13.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Adis%2C+Springer+International%22">Adis, Springer International </searchLink><i>Country of Publication: </i>New Zealand <i>NLM ID: </i>9504817 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1179-1918 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2211732563%22">11732563 </searchLink><i>NLM ISO Abbreviation: </i>Clin Drug Investig <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s40261-025-01428-9
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            – D: 01
              M: 04
              Text: 2025 Apr
              Type: published
              Y: 2025
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