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已发表论文
伏立康唑对健康受试者体内新型静脉麻醉剂环泊酚（HSK3486）安全性、药代动力学及药效学的影响：一项前瞻性、随机、交叉临床试验
Authors Bian Y , Hu T, Deng Q, Ma S, Jiao Y, Shi J, Jiang N, Hu M, Wang Y, Liu X, Zhang Z, Huang C, Zhang H, Miao L
Received 10 October 2025
Accepted for publication 19 December 2025
Published 8 January 2026 Volume 2026:20 562125
DOI https://doi.org/10.2147/DDDT.S562125
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Anastasios Lymperopoulos
Yicong Bian,1,2,* Tao Hu,1,2,* Qingqing Deng,1,3,* Sheng Ma,1,2 Yongyi Jiao,4 Jian Shi,1,2 Nan Jiang,5 Mengyue Hu,6 Yongrui Wang,6 Xiao Liu,6 Zihan Zhang,7 Chenrong Huang,1,2 Hua Zhang,1,2 Liyan Miao1,2
1Department of Pharmacy, the First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China; 2Institute for Interdisciplinary Drug Research and Translational Sciences, Soochow University, Suzhou, People’s Republic of China; 3College of Pharmaceutical Sciences, Soochow University, Suzhou, People’s Republic of China; 4Department of Anesthesiology, the First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China; 5Department of Radiology, the First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China; 6Department of Clinical Pharmacology, Haisco Pharmaceutical Group Co. Ltd., Chengdu, People’s Republic of China; 7Department of Pharmaceutical Sciences, Xi’an Jiaotong Liverpool University, Suzhou, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Liyan Miao, Department of Pharmacy, the First Affiliated Hospital of Soochow University, 899 Pinghai Road, Suzhou, People’s Republic of China, Tel +86 051267972858, Email miaoliyan@suda.edu.cn; miaolysuzhou@163.com Hua Zhang, Department of Pharmacy, the First Affiliated Hospital of Soochow University, 899 Pinghai Road, Suzhou, People’s Republic of China, Tel +86 051267972858, Email zhanghua_suzhou@163.com
Purpose: Ciprofol, a novel intravenous anaesthetic, is an analogue of propofol with superior anaesthetic efficacy. Ciprofol is widely metabolized in humans, and cytochrome P450 enzymes (CYPs) are involved in its metabolism. However, the drug‒drug interactions between ciprofol and drugs that may affect CYPs remains unclear. Therefore, we investigated the effects of voriconazole on the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ciprofol.
Methods: A randomized, two-period, two-sequence, crossover study was conducted in healthy participants who received a single intravenous dose of 0.4 mg/kg ciprofol (treatment A) and 0.4 mg/kg ciprofol after multiple doses of voriconazole (treatment B), a multiple inhibitor of CYP3A4/5, CYP2B6 and CYP2C9/19, in either sequence AB or sequence BA.
Results: MOAA/S-time curves revealed that the participants were anaesthetized rapidly (2.01 min versus 1.82 min) and recovered smoothly (11.58 min versus 11.64 min) after receiving ciprofol either alone or combined with voriconazole. The mean BISpeak values were 41.1 and 44.4, respectively. Voriconazole slightly increased the plasma AUC of ciprofol, but the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) for Cmax, AUC0-t and AUC0-∞ of plasma ciprofol were still in the range of 80%-125%, which demonstrated pharmacokinetic bioequivalence between the two treatments. No serious adverse effects were reported.
Conclusion: Ciprofol was well tolerated in combination with voriconazole, and the anaesthetic effect was satisfactory. The dose of ciprofol is suggested not be adjusted in patients receiving the CYP inhibitor voriconazole based on the PK, PD and safety characteristics.
Trial Registration: Clinicaltrials.gov, NCT04145583, registered on 25 October 2019.
Keywords: ciprofol, intravenous anaesthetic, drug-drug interaction, pharmacokinetics, pharmacodynamics, safety
1Department of Pharmacy, the First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China; 2Institute for Interdisciplinary Drug Research and Translational Sciences, Soochow University, Suzhou, People’s Republic of China; 3College of Pharmaceutical Sciences, Soochow University, Suzhou, People’s Republic of China; 4Department of Anesthesiology, the First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China; 5Department of Radiology, the First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China; 6Department of Clinical Pharmacology, Haisco Pharmaceutical Group Co. Ltd., Chengdu, People’s Republic of China; 7Department of Pharmaceutical Sciences, Xi’an Jiaotong Liverpool University, Suzhou, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Liyan Miao, Department of Pharmacy, the First Affiliated Hospital of Soochow University, 899 Pinghai Road, Suzhou, People’s Republic of China, Tel +86 051267972858, Email miaoliyan@suda.edu.cn; miaolysuzhou@163.com Hua Zhang, Department of Pharmacy, the First Affiliated Hospital of Soochow University, 899 Pinghai Road, Suzhou, People’s Republic of China, Tel +86 051267972858, Email zhanghua_suzhou@163.com
Purpose: Ciprofol, a novel intravenous anaesthetic, is an analogue of propofol with superior anaesthetic efficacy. Ciprofol is widely metabolized in humans, and cytochrome P450 enzymes (CYPs) are involved in its metabolism. However, the drug‒drug interactions between ciprofol and drugs that may affect CYPs remains unclear. Therefore, we investigated the effects of voriconazole on the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ciprofol.
Methods: A randomized, two-period, two-sequence, crossover study was conducted in healthy participants who received a single intravenous dose of 0.4 mg/kg ciprofol (treatment A) and 0.4 mg/kg ciprofol after multiple doses of voriconazole (treatment B), a multiple inhibitor of CYP3A4/5, CYP2B6 and CYP2C9/19, in either sequence AB or sequence BA.
Results: MOAA/S-time curves revealed that the participants were anaesthetized rapidly (2.01 min versus 1.82 min) and recovered smoothly (11.58 min versus 11.64 min) after receiving ciprofol either alone or combined with voriconazole. The mean BISpeak values were 41.1 and 44.4, respectively. Voriconazole slightly increased the plasma AUC of ciprofol, but the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) for Cmax, AUC0-t and AUC0-∞ of plasma ciprofol were still in the range of 80%-125%, which demonstrated pharmacokinetic bioequivalence between the two treatments. No serious adverse effects were reported.
Conclusion: Ciprofol was well tolerated in combination with voriconazole, and the anaesthetic effect was satisfactory. The dose of ciprofol is suggested not be adjusted in patients receiving the CYP inhibitor voriconazole based on the PK, PD and safety characteristics.
Trial Registration: Clinicaltrials.gov, NCT04145583, registered on 25 October 2019.
Keywords: ciprofol, intravenous anaesthetic, drug-drug interaction, pharmacokinetics, pharmacodynamics, safety