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

May 28, 2015 updated by: Novo Nordisk A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100730

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin aspart concentration-time curve from 0 to 24hours
Time Frame: 24 hours profile after single dose of trial drug
24 hours profile after single dose of trial drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin aspart concentration-time curve between different time intervals
Time Frame: 24 hours profile after single dose of trial drug
24 hours profile after single dose of trial drug
Maximum observed serum insulin aspart concentration
Time Frame: 24 hours profile after single dose of trial drug
24 hours profile after single dose of trial drug
Number of adverse events.
Time Frame: After 3-10 days of treatment
After 3-10 days of treatment
Number of hypoglycaemic events
Time Frame: After 3-10 days of treatment
After 3-10 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

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.

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

February 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3881
  • U1111-1116-2307 (Other Identifier: WHO)

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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