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

The Affiliated Hospital of Qingdao University32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Therapeutic Equivalency

Interventions

Liraglutide injectionDRUG

At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection

Liraglutide injection(Victoza®)DRUG

At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Phase I Clinical Research Center

Qingdao, Shandong, China

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Evaluation of Peak Plasma Concentration (Cmax)

Time frame: 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

Time frame: 40 days

Area under the plasma concentration versus time curve (AUC)0-∞

Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

Time frame: 40 days

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events

Collection of adverse events

Time frame: 40 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.