Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INL-001 · 1 trial · 1 indication
Maximum (peak) plasma concentration
Time to maximum (peak) plasma concentration
Lag-time
Terminal half-life
Terminal phase rate constant
Area under the plasma concentration-time curve from Time 0 to last time of last quantifiable plasma concentration (AUC0-last)
AUC from Time 0 to infinity
AUC = area under the plasma concentration-time curve;
| Arm | Type | Description |
|---|---|---|
| INL-001 | EXPERIMENTAL | 3 x 100 mg INL-001 (bupivacaine HCl collagen implants). Total bupivacaine HCl dose 300 mg. |
| Marcaine 0.25% infiltration | ACTIVE_COMPARATOR | Marcaine 0.25% infiltration (bupivacaine HCl 175 mg). |
| Name | Type | Description |
|---|---|---|
| INL-001 (bupivacaine HCl collagen implant) | COMBINATION_PRODUCT | 3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg) |
| Marcaine 0.25% infiltration | DRUG | Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration |
Inclusion Criteria: To be eligible for inclusion into the study, subjects must: * Be a man or woman ≥18 years of age. * Be eligible for unilateral inguinal hernioplasty with mesh (open laparotomy, tension-free technique) performed according to standard surgical technique under general anesthesia. ...