We are analyzing https://link.springer.com/article/10.1007/s12325-021-01914-4.

Title:
Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial | Advances in Therapy
Description:
The effects of continuous infusions of ciprofol on its pharmacodynamic and pharmacokinetic properties and safety profiles in healthy Chinese subjects were evaluated. In this open-label, randomized, two-way cross-over study, subjects received initial doses of continuous ciprofol/propofol as an infusion for 30 min in part 1 (n = 8) and a bolus dose in part 2 (n = 8) followed by maintenance infusions for a total of 4 h in part 1 and 12 h in part 2. Each subject participated in both parts with a washout time of at least 40 h. The safety and tolerability parameters of ciprofol were similar to those of propofol, and all treatment-emergent adverse events were mild. The incidences of injection pain and respiratory depression in subjects given ciprofol were lower than those receiving propofol. The pharmacokinetic parameters Cmax, tmax, t1/2, λz and MRT for ciprofol and propofol were similar, while CL, Vd and Vss were statistically significantly different. Pharmacodynamic parameters including the Richmond Agitation Sedation Scale and bispectral index profiles of ciprofol were similar to those of propofol. Ciprofol has potential for clinical application for continuous intravenous infusion to maintain sedation for 12 h with the same safety, tolerability and efficacy as propofol.
Website Age:
28 years and 1 months (reg. 1997-05-29).

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Keywords {🔍}

propofol, ciprofol, study, subjects, part, sedation, infusion, min, dose, article, pubmed, google, scholar, time, cas, maintenance, pain, injection, rass, continuous, safety, concentration, administration, plasma, parameters, clinical, drug, mgkgh, similar, studies, fig, end, initial, average, received, table, httpsdoiorg, data, phase, duration, china, healthy, lower, anesthesia, blood, liu, bolus, trial, properties, patients,

Topics {✒️}

treatment-emergent adverse events randomized placebo-controlled trial larger inter-individual variability article download pdf comparative canine pharmacokinetics-pharmacodynamics γ-aminobutyric acid type randomized split-body trial terminal elimination half-life open access fees steady-state plasma concentration lower inter-subject variability cyclodextrin-enabled propofol solution integrated pharmacokinetic-pharmacodynamic model steady-state distribution volume common drug-related teae target-controlled system plasma concentration-time curve propofol-positive controlled study inter-individual variability lc/ms–ms heart rate-time curve jia miao declare inter-subject variability long-term continuous infusion clinical trials center full access previous clinical trials privacy choices/manage cookies ciprofol dose/plasma exposure individual concentration-time data steady-state concentration treatment-emergent aes numerous clinical maneuvers plasma concentration-time profiles developed drug-related hypotension long-term propofol infusion vital signs teaes reach statistical significance dental care body mass index systolic blood pressure pharmacodynamic parameters including laboratory tests individual pd parameters pd parameters showed haisco pharmaceutical group meddra preferred term plasma sample collections respiratory-related teaes anesthesia-induced injection pain

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Schema {🗺️}

WebPage:
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         headline:Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial
         description:The effects of continuous infusions of ciprofol on its pharmacodynamic and pharmacokinetic properties and safety profiles in healthy Chinese subjects were evaluated. In this open-label, randomized, two-way cross-over study, subjects received initial doses of continuous ciprofol/propofol as an infusion for 30 min in part 1 (n = 8) and a bolus dose in part 2 (n = 8) followed by maintenance infusions for a total of 4 h in part 1 and 12 h in part 2. Each subject participated in both parts with a washout time of at least 40 h. The safety and tolerability parameters of ciprofol were similar to those of propofol, and all treatment-emergent adverse events were mild. The incidences of injection pain and respiratory depression in subjects given ciprofol were lower than those receiving propofol. The pharmacokinetic parameters Cmax, tmax, t1/2, λz and MRT for ciprofol and propofol were similar, while CL, Vd and Vss were statistically significantly different. Pharmacodynamic parameters including the Richmond Agitation Sedation Scale and bispectral index profiles of ciprofol were similar to those of propofol. Ciprofol has potential for clinical application for continuous intravenous infusion to maintain sedation for 12 h with the same safety, tolerability and efficacy as propofol.
         datePublished:2021-09-24T00:00:00Z
         dateModified:2021-09-24T00:00:00Z
         pageStart:5484
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            Oncology
            Cardiology
            Rheumatology
            Endocrinology
            Pharmacology/Toxicology
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ScholarlyArticle:
      headline:Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial
      description:The effects of continuous infusions of ciprofol on its pharmacodynamic and pharmacokinetic properties and safety profiles in healthy Chinese subjects were evaluated. In this open-label, randomized, two-way cross-over study, subjects received initial doses of continuous ciprofol/propofol as an infusion for 30 min in part 1 (n = 8) and a bolus dose in part 2 (n = 8) followed by maintenance infusions for a total of 4 h in part 1 and 12 h in part 2. Each subject participated in both parts with a washout time of at least 40 h. The safety and tolerability parameters of ciprofol were similar to those of propofol, and all treatment-emergent adverse events were mild. The incidences of injection pain and respiratory depression in subjects given ciprofol were lower than those receiving propofol. The pharmacokinetic parameters Cmax, tmax, t1/2, λz and MRT for ciprofol and propofol were similar, while CL, Vd and Vss were statistically significantly different. Pharmacodynamic parameters including the Richmond Agitation Sedation Scale and bispectral index profiles of ciprofol were similar to those of propofol. Ciprofol has potential for clinical application for continuous intravenous infusion to maintain sedation for 12 h with the same safety, tolerability and efficacy as propofol.
      datePublished:2021-09-24T00:00:00Z
      dateModified:2021-09-24T00:00:00Z
      pageStart:5484
      pageEnd:5500
      license:http://creativecommons.org/licenses/by-nc/4.0/
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         Ciprofol
         Sedation
         Safety
         Pharmacokinetics
         Pharmacodynamics
         Propofol
         Internal Medicine
         Oncology
         Cardiology
         Rheumatology
         Endocrinology
         Pharmacology/Toxicology
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               type:PostalAddress
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               type:PostalAddress
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      name:Xiaohong Zhu
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               type:PostalAddress
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      name:Yan Kang
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      name:Clinical Trials Center, West China Hospital, Sichuan University, Chengdu, China
      name:Clinical Trials Center, West China Hospital, Sichuan University, Chengdu, China
      name:Clinical Trials Center, West China Hospital, Sichuan University, Chengdu, China
      name:Department of Intensive Care Unit, West China Hospital, Sichuan University, Chengdu, China
      name:Clinical Trials Center, West China Hospital, Sichuan University, Chengdu, China

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