Effects of Voriconazole on the Safety, Pharmacokinetics and Pharmacodynamics of ...

연구 요약

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.

Drug design, development and therapy 학술지에 발표된 이 연구는 Bian Y, Hu T, Deng Q 외 연구팀이 수행하였습니다.

이 연구는 '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.'에 대한 과학적 분석을 제공합니다.

핵심 내용

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.

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