Therapeutic Equivalency
Conditions
Keywords
Liraglutide;Pharmacokinetic;bioequivalence
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.
Interventions
At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
DRUGLiraglutide injection(Victoza®)
At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 40 days | Evaluation of Peak Plasma Concentration (Cmax) |
| Area under the plasma concentration versus time curve (AUC)0-t | 40 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t |
| Area under the plasma concentration versus time curve (AUC)0-∞ | 40 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 40 days | Collection of adverse events |
Countries
China
Outcome results
None listed