Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects

Healthy Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242826
• Other study ID #: BIASP-3881
• Secondary ID: U1111-1116-2307
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2010
• Last updated: May 28, 2015
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: May 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• biphasic insulin aspart 50
A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin aspart concentration-time curve from 0 to 24hours		24 hours profile after single dose of trial drug	No
Secondary	Area under the serum insulin aspart concentration-time curve between different time intervals		24 hours profile after single dose of trial drug	No
Secondary	Maximum observed serum insulin aspart concentration		24 hours profile after single dose of trial drug	No
Secondary	Number of adverse events.		After 3-10 days of treatment	No
Secondary	Number of hypoglycaemic events		After 3-10 days of treatment	No

External Links

•   Clinical Trials at Novo Nordisk