A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: Faster-acting insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT02089451

NN1218-3949

2011-002590-32 (EudraCT Number)

U1111-1121-8351 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.

Enrollment

21 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, aged 18-64 years both inclusive at the time of signing informed consent
Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
Body mass index 20.0-28.0 kg/m^2 (both inclusive)

Exclusion criteria

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period