NCT03475732

Pharmacokinetics of XueBiJing in Patients With Sepsis

Pharmacokinetic Study of XueBiJing Injection in Patients With Sepsis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

Detailed description

XueBiJing injection, a five-herb combination approved by Chinese FDA in 2004, has been widely used as an add-on therapy in routine sepsis care in Chinese clinics. A comprehensive pharmacokinetic research on this herbal injection has been conducted in healthy human subjects, and the major circulating XueBiJing compounds, as well as their systemic exposure levels and forms and pharmacokinetic characteristics, have been identified. However, it is known that sepsis may induce hepatic, renal and cardiac dysfunction, alter drug metabolizing enzymes and transporters activities, increase capillary permeability, and induce various pathophysiological changes. All these will affect the concentrations at the action sites and pharmacokinetic characteristics of XueBiJing compounds, which contribute to the injection's overall therapeutic action, thus influencing the anti-septic efficacy of the injection. The purpose of this prospective, open label study is to identify the circulating XueBiJing compounds in patients with sepsis after intravenously dosing XueBiJing injection and their systemic exposure forms and levels, pharmacokinetic characteristics, and the associated inter-patient differences of these XueBiJing compounds.

Conditions

• Sepsis
• Septic Shock
• Community Acquired Pneumonia

Interventions

Type	Name	Description
DRUG	XueBiJing injection	100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days

Timeline

• Start date: 2018-03-18
• Primary completion: 2019-06-30
• Completion: 2019-12-31
• First posted: 2018-03-23
• Last updated: 2021-01-05

Locations

1 site across 1 country: China