Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study

Summary

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.

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  I004

  Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition.

• Drug
  NovoLog

  Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition.

Location