Clinical trial NCT05225974: A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects
Official title: A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Equivalency
Keywords: Liraglutide;Pharmacokinetic;bioequivalence
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 40 days
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 40 days
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 40 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 40 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
References: