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

Chongqing Medical University

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Device: Needle-free jet injection with insulin lispro; Device: Conventional pen injection with insulin lispro

Study type: Interventional

Funder types: Other

Identifiers

NCT02443714

NFJI-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The range of height should be 170±10cm.
2. The range of weight should be ±10%kg.
3. Liver and renal function should be normal.
4. Health subjects with no chronic diseases or medications.

Exclusion criteria

1. Drug allergy, history of allergic disorders or allergies.
2. A history of liver or kidney disease.
3. Smoker, drinkers.
4. Subjects who participated in other drug trials within a month.
5. Subjects who used medication which is known to organ damage.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 2 patient groups

Needle-free jet injection

Experimental group

Description:

Jet injectors deliver insulin at a high velocity (typically.100 m/s) across the skin in the subcutaneous tissue and may dispense the insulin over a larger area than insulin injected with a syringe.

Treatment:

Device: Needle-free jet injection with insulin lispro

Conventional pen

Experimental group

Description:

Conventional insulin administration with insulin pens.

Treatment:

Device: Conventional pen injection with insulin lispro