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NCT05486416 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery
A Phase 3 study, sponsored by Haisco-USA Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 465
- Enrollment target
NCT05486416 is a Phase 3 study that has completed, run by Haisco-USA Pharmaceuticals. The registered enrollment target is 465 participants.
The verdict
NCT05486416, a Phase 3 study, has completed, sponsored by Haisco-USA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 465 participants
- Enrollment target
Study Summary
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous \[IV\] slow injection over 30 \[±5\] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 \[±5\] seconds for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.
Interventions
- DRUG Propofol
- DRUG HSK3486
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2024-01-12 |
| Est. Completion | 2024-07-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05486416
The ClinicalTrials.gov registry entry for NCT05486416 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 465 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Haisco-USA Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Propofol is the first listed.
NCT05486416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05486416 about?
NCT05486416 is a clinical study titled "Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery". To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous \[IV\] slow injection over 30 \[±5\] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 \[±5\] seconds for first dose, an additional 1.0 mg/kg if nee...
What is the current status of trial NCT05486416?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2024-01-12. Estimated completion is 2024-07-23.
What interventions are being tested in trial NCT05486416?
The interventions under investigation include: Propofol (DRUG), HSK3486 (DRUG).
Who is sponsoring clinical trial NCT05486416?
This trial is sponsored by Haisco-USA Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
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