Skip to content

Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01437592
Enrollment
24
Registered
2011-09-21
Start date
2011-09-06
Completion date
2011-11-22
Last updated
2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGinsulin degludec

For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Area under the serum insulin degludec concentration-time curveFrom 0 to 120 hours after single dose

Secondary

MeasureTime frame
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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026