Status:
COMPLETED
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.
Detailed Description
During Dosing Period 1, blood samples for pharmacokinetic (PK) analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 12 hours postdose (i.e., at 15 and 30 minutes, ...
Eligibility Criteria
Inclusion
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1 or 2.
- Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before the first study drug administration.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Exclusion
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- History of abnormal bleeding tendencies/clotting disorders.
- Regular use of anticoagulants (except for low dose aspirin for cardioprotection).
- Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during his/her participation in this study.
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
- Received bupivacaine or other local anesthetic within 7 days of first study drug administration.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02210247
Start Date
August 1 2014
End Date
September 1 2014
Last Update
July 6 2021
Active Locations (1)
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1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227