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Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
Registration Number
NCT01437592
Lead Sponsor
Novo Nordisk A/S
Brief Summary

This trial was conducted in Asia. The aim of this trial was to investigate the pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250 (insulin degludec) in healthy Chinese subjects.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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
  • Not able or willing to refrain from smoking during the inpatient period

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
IDeginsulin degludec-
Primary Outcome Measures
NameTimeMethod
Area under the serum insulin degludec concentration-time curveFrom 0 to 120 hours after single dose
Secondary Outcome Measures
NameTimeMethod
Maximum observed serum insulin degludec concentration0-24 hours (derived on treatment day 1).
Time to maximum observed serum insulin degludec concentration0-24 hours (derived on treatment day 1).

Trial Locations

Locations (1)

Novo Nordisk Investigational Site

🇨🇳

Beijing, Beijing, China

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