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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic insulin aspart 50

Study type: Interventional

Funder types: Industry

Identifiers

NCT01242826

BIASP-3881

U1111-1116-2307 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

A

Experimental group

Treatment:

Drug: biphasic insulin aspart 50