Status:
COMPLETED
A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Therapeutic Equivalency
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05225974
Start Date
July 16 2021
End Date
August 19 2021
Last Update
February 7 2022
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003