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

Therapeutic Equivalency Clinical Trial

Official title:
A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study

Clinical Trial 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.

Clinical Trial Description

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.Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza® or Liraglutide injection by subcutaneous injection during the first period. Following 7 days washout period, all subjects received the alternate formulation during the second period. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05225974
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact
Status Completed
Phase Phase 1
Start date July 16, 2021
Completion date August 19, 2021
View Details
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