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

NCT05225974 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-07

No results posted yet for this study

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.

Conditions

  • Therapeutic Equivalency

Interventions

DRUG

Liraglutide injection

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

DRUG

Liraglutide injection(Victoza®)

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

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-16
Primary Completion
2021-07-30
Completion
2021-08-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225974 on ClinicalTrials.gov