NCT04158102

Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects

A Phase 1, Open Label Study to Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Nuance Pharma (shanghai) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects

Detailed description

This is a phase I, open-label, single-dose in healthy subjects conducted at single center.The objectives are to evaluate the metabolic and safety profile of EXPAREL®. Each volunteer will receive one dose of the investigational drug via subcutaneous injection at multiple points during the study period. Study duration is around 54 days, including screening, confinement, ambulatory visit and a phone follow up.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Bupivacaine liposome injectable suspension	Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL

Timeline

• Start date: 2019-11-07
• Primary completion: 2019-12-17
• Completion: 2019-12-26
• First posted: 2019-11-08
• Last updated: 2020-01-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study