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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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