Overview

Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Status:
Completed
Trial end date:
2015-03-23
Target enrollment:
0
Participant gender:
All
Summary
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Innocoll
Collaborator:
Premier Research Group plc
Treatments:
Bupivacaine
Criteria
Inclusion Criteria:

1. Man or woman who is ≥ 18 years of age

2. Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free
technique)

3. If female, is nonpregnant

Exclusion Criteria:

1. Scheduled for bilateral inguinal hernioplasty or other significant concomitant
surgical procedures

2. Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to
undergo another laparotomy procedure within 30 days postoperatively

3. Has any clinically significant unstable cardiac, neurological, immunological, renal,
hepatic or hematological disease or any other condition that, in the opinion of the
investigator, could compromise the patient's welfare, ability to communicate with the
study staff or otherwise contraindicate study participation