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NCT04293809 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
A Phase 1 study of Breast Augmentation, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04293809: Completed Phase 1 study of Breast Augmentation, sponsored by Pacira Pharmaceuticals.
NCT04293809 is a Phase 1 study of Breast Augmentation that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04293809, a Phase 1 study of Breast Augmentation, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.
Primary Outcome
Area under the plasma concentration-versus-time curve (AUC)
Conditions Studied
Interventions
- DRUG Bupivacaine Hydrochloride
- DRUG Exparel Injectable Product
Study Locations (1)
Texas
- HD Research - Bellaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2020-01-29 |
| Phase | Phase 1 |
What the finished NCT04293809 record still lists
NCT04293809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Breast Augmentation appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine Hydrochloride is the first listed.
NCT04293809 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04293809 about?
NCT04293809 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation". This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.
What is the current status of trial NCT04293809?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-12-19. Estimated completion is 2020-01-29.
What conditions does trial NCT04293809 study?
This clinical trial studies the following conditions: Breast Augmentation.
What interventions are being tested in trial NCT04293809?
The interventions under investigation include: Bupivacaine Hydrochloride (DRUG), Exparel Injectable Product (DRUG).
Who is sponsoring clinical trial NCT04293809?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04293809 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04293809's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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