Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Study Overview
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Brief Summary
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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.

Detailed Description
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Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity after open mesh hernioplasty remain considerable medical challenges. Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The Xaracoll implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the surgical site to provide postoperative pain control. This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant compared to a local bupivacaine infiltration.

Official Title
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A Randomized, Blinded, Inpatient Study to Investigate the PK, Relative Bioavailability and Safety of 2 Doses of XaraColl (200 and 300 mg Bupivacaine HCl) Compared to Bupivacaine HCl Infiltration (150 mg) After Open Laparotomy Hernioplasty

Conditions
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Hernioplasty

Intervention / Treatment
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* Drug: 2 100mg Xaracoll implants
* Drug: 3 100mg Xaracoll implants
* Drug: 150mg Bupivacaine HCl injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman who is ≥ 18 years of age Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique) If female, is nonpregnant Exclusion Criteria: Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 100mg Xaracoll implants<br>Bupivacaine HCl implant | Drug: 2 100mg Xaracoll implants<br> <br> * Other names: Bupivacaine HCl implant;|
| Experimental: 3 100mg Xaracoll implants<br>Bupivacaine HCl implant | Drug: 3 100mg Xaracoll implants<br> <br> * Other names: Bupivacaine HCl implant;|
| Active Comparator: 150mg Bupivacaine HCl injection<br>Bupivacaine HCl | Drug: 150mg Bupivacaine HCl injection<br> <br> * Other names: Bupivacaine HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum drug plasma concentration | 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery. | 
| AUC0-last | Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration. | 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery. | 
| Tmax | Time to maximum plasma concentration. | 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery. | 
| t1/2 (Hour) | Terminal half-life. | 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unilateral inguinal hernioplasty