Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.