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NCT04173611 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers
A Phase 1 study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04173611 is a Phase 1 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 20 participants.
The verdict
NCT04173611, a Phase 1 study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Primary objective: To assess the safety and tolerability of EXPAREL® administered as a single intrathecal injection in healthy volunteers Secondary objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EXPAREL® administered as a single intrathecal injection in healthy volunteers
Interventions
- OTHER Placebo
- DRUG Bupivacaine Hydrochloride
- DRUG EXPAREL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04173611
The ClinicalTrials.gov registry entry for NCT04173611 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04173611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04173611 about?
NCT04173611 is a clinical study titled "Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers". Primary objective: To assess the safety and tolerability of EXPAREL® administered as a single intrathecal injection in healthy volunteers Secondary objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EXPAREL® administered as a single intrathecal injection in heal...
What is the current status of trial NCT04173611?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-06-08. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT04173611?
The interventions under investigation include: Placebo (OTHER), Bupivacaine Hydrochloride (DRUG), EXPAREL (DRUG).
Who is sponsoring clinical trial NCT04173611?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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