A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects
- Sponsor
- The Affiliated Hospital of Qingdao University
- Study ID
- NCT05225974
- Phase
- PHASE1
- Status
- Completed
Conditions
- Therapeutic Equivalency
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Liraglutide injection — DRUGAt a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
- Liraglutide injection(Victoza®) — DRUGAt a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection
Study Details
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.
Key Dates
- Start date
- Jul 16, 2021
- Status verified
- Jan 2022
- Primary completion
- Jul 30, 2021
- Completion
- Aug 19, 2021
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Experimental: Liraglutide injection
- Active Comparator: Liraglutide injection(Victoza®)
Primary Outcome Measure
Peak Plasma Concentration (Cmax) [ Time Frame: 40 days ]