A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUC)0-∞
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male vulunteers aged 18 and above.
- •The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
- •Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
Exclusion Criteria
- •Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
- •Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
- •Participation in another clinical trial within 3 months.
- •Smoking more than 5 cigarettes per day during the 3 months prior to screening.
- •Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
- •Any use of other prescription drugs (including contraceptive)#over-thecounter drugs, Chinese herbal medicine, health care products and 30 days prior to medication for this study.
Arms & Interventions
Liraglutide injection
Intervention: Liraglutide injection (Drug)
Liraglutide injection(Victoza®)
Intervention: Liraglutide injection(Victoza®) (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUC)0-∞
Time Frame: 40 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)
Time Frame: 40 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
Time Frame: 40 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events(40 days)