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A Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing Colonoscopy

NCT04470128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-02-21

No results posted yet for this study

Summary

This is a multi-center, randomized, two-stage, phase II clinical study .The main objective is to evaluate the safety and tolerability of HSK21542 injection for analgesia in patients undergoing colonoscopy, and, combining the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics

Conditions

  • Analgesia

Interventions

DRUG

Stage I: HSK21542 0.5 μg/kg

intravenous injection

DRUG

Stage I: HSK21542 1 μg/kg

intravenous injection

DRUG

HSK21542 0.5 μg/kg

intravenous injection

DRUG

HSK21542 1 μg/kg

intravenous injection

DRUG

HSK21542 2 μg/kg

intravenous injection

DRUG

Placebo

intravenous injection

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2020-12-28
Completion
2021-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04470128 on ClinicalTrials.gov