Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty

Phase 1 Completed 52 enrolled Innocoll Medpace, Inc. · collab

RandomizedParallel-groupSingle-blindOther

Summary

This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.

Timeline

Start: 2017-06-02
Primary completion: 2017-08-15
Completion: 2017-08-15

Publications

Leiman D, Niebler G, Minkowitz HS. Pharmacokinetics and Safety of INL-001 (Bupivacaine HCl) Implants Compared with Bupivacaine HCl Infiltration After Open Unilateral Inguinal Hernioplasty. Adv Ther. 2021 Jan;38(1):691-706. doi: 10.1007/s12325-020-01565-x. Epub 2020 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupivacaine	Other / unclassified	175 mg	Other
Comparator	Bupivacaine	Other / unclassified	300 mg	Other

Indications

No indication recorded.