A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects

Phase 1 Completed 32 enrolled The Affiliated Hospital of Qingdao University

RandomizedCrossoverOpen-labelOther

Summary

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.

Timeline

Start: 2021-07-16
Primary completion: 2021-07-30
Completion: 2021-08-19

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	0.6 mg	Subcutaneous

Indications

No indication recorded.