PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Inclusion criteria

• Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject
• Healthy male subjects
• Age between 18 and 64 years, both inclusive
• Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive
• Fasting plasma glucose concentration <= 5.50 mmol/L (100 mg/dL) at screening
• Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator

Exclusion criteria

• Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related product
• Previous participation in this trial. Participation is defined as randomized
• Use of other investigational drugs within five half-lives for enrolment or receipt of any medicinal product in clinical development within 30 days before randomization in this trial, whichever is longer
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator
• Increased risk of thrombosis, e.g subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
• A positive result in the alcohol and/or urine drug screen at the screening visit
• Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
• Blood donation or blood loss of m ore than 500 mL within the last 3 months