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已发表论文
SHR0302 口服溶液和片剂的药代动力学、相对生物利用度及安全性：一项在中国健康志愿者中开展的单中心、随机、开放标签、交叉（两制剂、两周期）I 期临床试验
Authors Gao X, Shen K , Tang D, Bai W, Wang J, Wang T, Wang X
Received 23 December 2024
Accepted for publication 17 September 2025
Published 26 September 2025 Volume 2025:19 Pages 8783—8792
DOI https://doi.org/10.2147/DDDT.S513537
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Professor Anastasios Lymperopoulos
Xin Gao,1 Kai Shen,2 Dan Tang,2 Wenjing Bai,1 Juan Wang,1 Tingting Wang,1 Xin Wang1
1Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application, Beijing, People’s Republic of China; 2Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, People’s Republic of China
Correspondence: Xin Wang, Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application, No. 1 Da Hua Road, Dong Dan, Beijing, 100730, People’s Republic of China, Tel +86-10-58115037, Email wangxinannie@126.com
Purpose: This study investigates the pharmacokinetic characteristics and relative bioavailability of SHR0302 oral solution and tablets in healthy Chinese male volunteers.
Patients and Methods: This single-center, randomized, open-label, crossover (two-formulation, two-period) phase I study enrolled 16 healthy male volunteers. Participants were randomized 1:1 to receive single dose 8mg of either the SHR0302 oral solution or the SHR0302 tablet. Blood samples were collected according to the protocol requirements, and SHR0302 plasma concentrations were analyzed using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Pharmacokinetic parameters were calculated using a non-compartmental analysis in Phoenix WinNonlin (version 8.3). Data processing and analysis of pharmacokinetic characteristics and relative bioavailability were conducted using SAS software (version 9.4). Safety was assessed through treatment-emergent adverse events (TEAEs), vital signs, physical examinations, 12-lead electrocardiograms, and laboratory tests.
Results: All 16 enrolled subjects completed the study. The geometric mean ratio (90% confidence interval) for Cmax of SHR0302 oral solution versus tablets was 1.04 (0.998, 1.09), and the geometric mean ratios (90% confidence intervals) for AUC0–t and AUC0–inf were both 1.04 (1.02, 1.06). These results fell entirely within the bioequivalence range of 80% to 125%. Among the 16 subjects, 5 (31.3%) experienced a total of 6 TEAEs, all of which were mild in severity. No serious adverse events were reported.
Conclusion: In healthy Chinese male volunteers, the bioavailability of the SHR0302 oral solution was comparable to that of the SHR0302 tablet. The drug was safe and well tolerated following a single dose.
Keywords: pharmacokinetics research, comparative bioavailability, different dosage forms, healthy Chinese male subjects
1Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application, Beijing, People’s Republic of China; 2Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, People’s Republic of China
Correspondence: Xin Wang, Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application, No. 1 Da Hua Road, Dong Dan, Beijing, 100730, People’s Republic of China, Tel +86-10-58115037, Email wangxinannie@126.com
Purpose: This study investigates the pharmacokinetic characteristics and relative bioavailability of SHR0302 oral solution and tablets in healthy Chinese male volunteers.
Patients and Methods: This single-center, randomized, open-label, crossover (two-formulation, two-period) phase I study enrolled 16 healthy male volunteers. Participants were randomized 1:1 to receive single dose 8mg of either the SHR0302 oral solution or the SHR0302 tablet. Blood samples were collected according to the protocol requirements, and SHR0302 plasma concentrations were analyzed using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Pharmacokinetic parameters were calculated using a non-compartmental analysis in Phoenix WinNonlin (version 8.3). Data processing and analysis of pharmacokinetic characteristics and relative bioavailability were conducted using SAS software (version 9.4). Safety was assessed through treatment-emergent adverse events (TEAEs), vital signs, physical examinations, 12-lead electrocardiograms, and laboratory tests.
Results: All 16 enrolled subjects completed the study. The geometric mean ratio (90% confidence interval) for Cmax of SHR0302 oral solution versus tablets was 1.04 (0.998, 1.09), and the geometric mean ratios (90% confidence intervals) for AUC0–t and AUC0–inf were both 1.04 (1.02, 1.06). These results fell entirely within the bioequivalence range of 80% to 125%. Among the 16 subjects, 5 (31.3%) experienced a total of 6 TEAEs, all of which were mild in severity. No serious adverse events were reported.
Conclusion: In healthy Chinese male volunteers, the bioavailability of the SHR0302 oral solution was comparable to that of the SHR0302 tablet. The drug was safe and well tolerated following a single dose.
Keywords: pharmacokinetics research, comparative bioavailability, different dosage forms, healthy Chinese male subjects