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