Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects
A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) in Healthy Chinese Subjects
2 other identifiers
interventional
24
1 country
1
Brief Summary
This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started Feb 2011
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMay 29, 2015
May 1, 2015
28 days
November 16, 2010
May 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the serum insulin aspart concentration-time curve from 0 to 24hours
24 hours profile after single dose of trial drug
Secondary Outcomes (4)
Area under the serum insulin aspart concentration-time curve between different time intervals
24 hours profile after single dose of trial drug
Maximum observed serum insulin aspart concentration
24 hours profile after single dose of trial drug
Number of adverse events.
After 3-10 days of treatment
Number of hypoglycaemic events
After 3-10 days of treatment
Study Arms (1)
A
EXPERIMENTALInterventions
A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection
Eligibility Criteria
You may qualify if:
- Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician)
- Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive)
You may not qualify if:
- Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician)
- A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a 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 (trial entry)
- Not able or willing to refrain from smoking during the inpatient period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Beijing, Beijing Municipality, 100730, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 17, 2010
Study Start
February 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
May 29, 2015
Record last verified: 2015-05