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A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: insulin degludec/insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT02844790
U1111-1173-7678 (Other Identifier)
NN5401-1984

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in healthy Chinese subjects.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female Chinese subject aged 18-45 years (both inclusive)
  • Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the investigator
  • Body mass index 19.0-24.0 kg/m^2 (both inclusive)

Exclusion criteria

  • A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
  • Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
  • Smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

IDegAsp
Experimental group
Treatment:
Drug: insulin degludec/insulin aspart

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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