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

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

June 2, 2017

Primary Completion Date

August 15, 2017

Study Completion Date

August 15, 2017

Conditions
Hernioplasty
Interventions
COMBINATION_PRODUCT

INL-001 (bupivacaine HCl collagen implant)

3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)

DRUG

Marcaine 0.25% infiltration

Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration

Trial Locations (5)

32750

Park Place Surgery Center, Longwood

36207

Pinnacle Research Group, Anniston

77004

Research Concepts, Houston

77027

Research Concepts GP, LLC - Houston, Houston

84124

Jean Brown Research, Salt Lake City

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Medpace, Inc.

INDUSTRY

lead

Innocoll

INDUSTRY

NCT03234374 - Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty | Biotech Hunter | Biotech Hunter