NCT02443714

Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Needle-free jet injector provides an alternative for patients with diabetes treated by insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD) profiles of lispro administered by jet injector and conventional pen.

Detailed description

This is a randomized, double-blind, double-dummy, crossover study. Eighteen healthy volunteers will be recruited. Lispro (0.2 units/kg) will be administered by jet injector or by conventional pen and a seven-hour euglycemic clamp test will be performed. PK-PD profiles of lispro will be calculated.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Needle-free jet injection with insulin lispro	Subjects injected by jet injectors which deliver insulin lispro
DEVICE	Conventional pen injection with insulin lispro	Subjects injected by conventional insulin pens which deliver insulin lispro

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-05-14
• Last updated: 2015-09-28

Locations

1 site across 1 country: China