AIM: To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two recombinant human insulin injection by euglycemic clamp technology in healthy male subjects after a single subcutaneous injection. METHODS: We conducted a randomized, open-label, single dose, two period, crossover study. A total of 24 healthy male subjects were enrolled and randomized to receive single subcutaneous doses (0.2 U/kg) of the investigational products every period. The PK and PD characteristics were assessed by euglycemic clamp up to 14 hours after dosing. RESULTS: Euglycemic clamp technique was successfully established. C-peptide levels detected at each time point before and after administration indicated that endogenous insulin secretion was inhibited in the two groups after administration. The geometric mean ratio of Cmax and AUC0-t and 90% confidence interval (CI) of test preparation and reference preparation under fasting condition were in the range of 80.00%-125.00%. CONCLUSION: The human insulin produced by KP Biotech demonstrated similarity to the reference preparation Humulin? in PK and PD characteristics in healthy Chinese subjects.