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Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

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ClinicalTrials.gov Identifier: NCT01437592
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: insulin degludec Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
Study Start Date : September 2011
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: IDeg Drug: insulin degludec
For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)



Primary Outcome Measures :
  1. Area under the serum insulin degludec concentration-time curve [ Time Frame: From 0 to 120 hours after single dose ]

Secondary Outcome Measures :
  1. Maximum observed serum insulin degludec concentration [ Time Frame: 0-24 hours (derived on treatment day 1). ]
  2. Time to maximum observed serum insulin degludec concentration [ Time Frame: 0-24 hours (derived on treatment day 1). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437592


Locations
China, Beijing
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01437592     History of Changes
Other Study ID Numbers: NN1250-1999
U1111-1122-6475 ( Other Identifier: WHO )
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015