Status and phase
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About
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
Enrollment
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Inclusion criteria
Exclusion criteria
Patients having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
Patients with past history of allergy or contraindications to opioids, their rescue medications, and propofol;
Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk:
Patients with the following airway management risks:
In receipt of any one of the following medications or treatments at screening:
Patient whose laboratory parameters measured at screening reach the following criteria and are verified through reexamination:
Having participated in other drug clinical trials within 3 months prior to screening (defined as having received investigational product or placebo);
Pregnant or breastfeeding females: women or men of child-bearing potential who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 3 months after the trial (including male subjects);
Subject judged by the investigator to have any other factors unsuitable for involvement in the study.
Primary purpose
Allocation
Interventional model
Masking
180 participants in 6 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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