A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Liraglutide injection
|
Drug: Liraglutide injection
At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
|
| Active Comparator: Liraglutide injection(Victoza®)
|
Drug: Liraglutide injection(Victoza®)
At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [40 days]
Collection of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male vulunteers aged 18 and above.
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The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
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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:
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Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
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Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
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Participation in another clinical trial within 3 months.
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Smoking more than 5 cigarettes per day during the 3 months prior to screening.
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Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phase I Clinical Research Center | Qingdao | Shandong | China | 266003 |
Sponsors and Collaborators
- The Affiliated Hospital of Qingdao University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NBT-1698-P1