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.
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Observed Plasma Concentration (Cmax)
Timeframe: Baseline through 72 hours after start of study drug administration
Area Under the Concentration-time Curve From Time 0 to the Last Collection Time After Study Drug Administration (AUC Last)
Timeframe: Baseline through 72 hours after start of study drug administration
Area Under the Concentration-time Curve From Time 0 to Infinity After Study Drug Administration (AUC∞)
Timeframe: Baseline through 72 hours after start of study drug administration
Time to Maximum Plasma Concentration (Tmax)
Timeframe: Baseline through 72 hours after start of study drug administration
The Apparent Terminal Elimination Rate Constant (λz)
Timeframe: Baseline through 72 hours after start of study drug administration
The Apparent Terminal Elimination Half-life (t1/2el)
Timeframe: Baseline through 72 hours after start of study drug administration