This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Upon review, agree to participate and sign informed consent.
Healthy male and female subjects ≥ 18 to ≤ 65 years of age.
Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2
Weight ≥ 50 kg.
History of diabetes mellitus.
Resting blood pressure (BP) > 140/90 mmHg or < 90/60 mmHg. Subjects BP may be re-checked.
Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
History of any serious adverse reaction or hypersensitivity to any of the investigational product components.