Trials / Completed
CompletedNCT03705065
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty
A Phase 4, Randomized, Open-Label Study of the Pharmacokinetics and Tolerability of Bupivacaine HCl Following One of Two Routes of Administration in Subjects Undergoing Augmentation Mammoplasty
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bupivacaine HCl | Bupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket) |
Timeline
- Start date
- 2018-09-19
- Primary completion
- 2018-10-08
- Completion
- 2018-11-05
- First posted
- 2018-10-15
- Last updated
- 2018-12-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03705065. Inclusion in this directory is not an endorsement.