- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497587
Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan
January 30, 2017 updated by: Novo Nordisk A/S
A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects
This trial is conducted in Asia.
The aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy Taiwanese subjects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 112
- Novo Nordisk INvestigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Considered generally healthy upon completion of medical history and physical examination as judged by the investigator
- Body mass index (BMI) between 18 and 27 kg/m^2, inclusive
- Fasting plasma glucose maximum 6.1 mmol/l
- Non-smoker or smoking maximum 5 cigarettes per day or the equivalent
Exclusion Criteria:
- Participation in any other clinical trial involving other investigational products within the last 3 months
- Subject with a history of alcohol or drug dependence
- Subject with a first-degree relative with diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insulin detemir
|
Single dose, 0.5 U/kg, administered s.c.
(under the skin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Area under the insulin detemir concentration curve
|
Secondary Outcome Measures
Outcome Measure |
---|
Maximum insulin detemir concentration
|
Time to maximum insulin detemir concentration
|
The mean residence time of insulin detemir
|
Insulin detemir half-life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kwok C-F, Tsai T-H, Lim S-H, Vaz J, Ho L-T. The Pharmacokinetic Profile of Insulin Detemir in Healthy Male Taiwanese and Caucasian Subjects. ASEAN Federation of Endocrine Societies (AFES); Country: Malaysia City: Kuala Lumpur
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
December 20, 2011
First Submitted That Met QC Criteria
December 20, 2011
First Posted (Estimate)
December 22, 2011
Study Record Updates
Last Update Posted (Estimate)
January 31, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-3023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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