Liraglutide injection bioequivalence assessed in healthy Chinese subjects for pharmacokinetic and safety profiles

Developing generic or biosimilar versions of established drugs like Liraglutide is crucial for increasing patient access and reducing healthcare costs. For a new formulation to be approved, it must demonstrate bioequivalence, meaning it delivers the active pharmaceutical ingredient to the site of action at the same rate and extent as the reference product. This ensures comparable efficacy and safety. This study aimed to assess the pharmacokinetic (PK) profile and safety of a novel Liraglutide injection compared to the established Victoza® in a specific population, addressing the need for local market alternatives.

This single-site, randomized, open-label, crossover study enrolled 32 healthy Chinese adult male volunteers. Participants received a single subcutaneous dose of 0.6 mg Liraglutide injection (test product) and Victoza® (reference product) under fasted conditions in two separate periods. Blood samples were collected up to 72 hours post-administration to determine pharmacokinetic parameters. Primary pharmacokinetic endpoints included AUC0-t (area under the curve from time 0 to the last measurable concentration), AUC0-∞ (area under the curve from time 0 to infinity), and Cmax (maximum plasma concentration). Safety profiles and immunogenicity data were also collected throughout the study duration.

The abstract describes the design of a Phase 1 study to evaluate the pharmacokinetic profile, safety, and immunogenicity of a 0.6 mg Liraglutide injection compared to Victoza® in healthy Chinese subjects. It specifies that blood samples were collected for 72 hours to determine key pharmacokinetic parameters such as AUC0-t, AUC0-∞, and Cmax. Safety and immunogenicity data were also gathered. However, the abstract does not provide any specific numerical results regarding the measured pharmacokinetic parameters (e.g., mean Cmax, AUC ratios, or confidence intervals) or the safety and immunogenicity findings. Therefore, no quantitative data on bioequivalence or adverse event rates can be reported from this abstract.