Liaoning Bo'ao Bio-pharmaceutical Co., Ltd.

Primary objective: To evaluate the bioequivalence of the two preparations in healthy Chinese male subjects by using pharmacokinetic and pharmacodynamic parameters, using insulin aspart 30 injection (NovoRapid 30) produced by Novo Nordisk A/S as the reference preparation and insulin aspart 30 injection produced by Liaoning Boao Biopharmaceutical Co., Ltd. as the test preparation in a single-center, randomized, blinded, two-period, double-crossover euglycemic glucose clamp study. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese male subjects.

A hyperinsulinemic-euglycemic glucose clamp study was designed to evaluate the bioequivalence of the test formulation and the reference formulation in healthy Chinese male subjects using pharmacokinetic and pharmacodynamic parameters.

Using Lentis (insulin glargine injection) as the reference preparation and insulin glargine injection produced by Liaoning Boao Biopharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, blinded, two-period, double-crossover hyperinsulinemic-euglycemic glucose clamp study was conducted to evaluate the bioequivalence and safety of the two preparations in healthy Chinese male subjects using pharmacokinetic and pharmacodynamic parameters.