NCT05225974

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Therapeutic Equivalency

Interventions

Type	Name	Description
DRUG	Liraglutide injection	At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
DRUG	Liraglutide injection(Victoza®)	At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection

Timeline

• Start date: 2021-07-16
• Primary completion: 2021-07-30
• Completion: 2021-08-19
• First posted: 2022-02-07
• Last updated: 2022-02-07

Locations

1 site across 1 country: China