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drugset / Trial / NCT04785638

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries

NCT04785638 ↗

Phase 3 Completed 100 enrolled Innocoll
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.

Timeline

Start
2021-04-14
Primary completion
2023-01-10
Completion
2023-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 300 mg Other

Indications

No indication recorded.