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A Study to Evaluate the Differences in Pharmadynamics, Pharmacokinetics, and Safety Between Ciprofol and Propofol

NCT04294056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-20

No results posted yet for this study

Summary

This is a single-center, open-label, randomized, two-stage, two-way crossover Phase I study in healthy male subjects.The main objective is to evaluate the differences in pharmadynamics (PD), pharmacokinetics (PK), and safety between ciprofol injectable emulsion and propofol injectable emulsion at different doses in healthy subjects.

Conditions

  • Anesthesia

Interventions

DRUG

Ciprofol

First-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg Second-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg

DRUG

Propofol

First-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg Second-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2020-06-22
Completion
2020-09-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294056 on ClinicalTrials.gov