A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study

Conditions
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Therapeutic Equivalency

Intervention / Treatment
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* Drug: Liraglutide injection
* Drug: Liraglutide injection(Victoza®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide injection<br> | Drug: Liraglutide injection<br>* At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection<br>|
| Active Comparator: Liraglutide injection(Victoza®)<br> | Drug: Liraglutide injection(Victoza®)<br>* At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 40 days | 
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 40 days | 
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liraglutide;Pharmacokinetic;bioequivalence