Trial reportDrug design, development and therapy2026
Effects of Voriconazole on the Safety, Pharmacokinetics and Pharmacodynamics of Ciprofol (HSK3486), a Novel Intravenous Anaesthetic, in Healthy Participants: A Prospective, Randomized, Crossover Clinical Trial.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04145583 (A Single-Center, Open-Label, Randomized, Two-Stage, and Two-Way Crossover Study Evaluating Drug-Drug Interaction), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Single-Center, Open-Label, Randomized, Two-Stage, and Two-Way Crossover Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets in Healthy Subjects
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Authors and funding
14 authors.
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Abstract
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 BIS 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.
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