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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Needle-free jet injection

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.

Group Type EXPERIMENTAL

Needle-free jet injection with insulin lispro

Intervention Type DEVICE

Subjects injected by jet injectors which deliver insulin lispro

Conventional pen

Conventional insulin administration with insulin pens.

Group Type EXPERIMENTAL

Conventional pen injection with insulin lispro

Intervention Type DEVICE

Subjects injected by conventional insulin pens which deliver insulin lispro

Interventions

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Needle-free jet injection with insulin lispro

Subjects injected by jet injectors which deliver insulin lispro

Intervention Type DEVICE

Conventional pen injection with insulin lispro

Subjects injected by conventional insulin pens which deliver insulin lispro

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes