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NCT04819581 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
A Phase 1 study of Healthy, sponsored by Scilex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04819581: Completed Phase 1 study of Healthy, sponsored by Scilex Pharmaceuticals.
NCT04819581 is a Phase 1 study of Healthy that has completed, run by Scilex Pharmaceuticals. The registered enrollment target is 15 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04819581, a Phase 1 study of Healthy, has completed, sponsored by Scilex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.
Primary Outcome
Peak plasma concentration of lidocaine after 12 hour topical system application
Conditions Studied
Interventions
- DRUG SP-103
- DRUG ZTlido
Study Locations (1)
Minnesota
- AXIS Clinicals - Dilworth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-08-03 |
| Est. Completion | 2019-08-27 |
| Phase | Phase 1 |
What the finished NCT04819581 record still lists
NCT04819581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which SP-103 is the first listed.
NCT04819581 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04819581 about?
NCT04819581 is a clinical study titled "Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects". This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.
What is the current status of trial NCT04819581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-08-03. Estimated completion is 2019-08-27.
What conditions does trial NCT04819581 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04819581?
The interventions under investigation include: SP-103 (DRUG), ZTlido (DRUG).
Who is sponsoring clinical trial NCT04819581?
This trial is sponsored by Scilex Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04819581 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04819581's enrollment target sits among peer trials
15 955th of 1090 higher than 118 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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