Human Bioequivalence Test of Liraglutide Injection

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT05029076
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Liraglutide injection — DRUG
    Human glucagon-like peptides-1 analogue
  • Victoza — DRUG
    Human glucagon-like peptides-1 analogue

Study Details

To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation Victoza ® in healthy subjects.

Key Dates

Start date
May 21, 2019
Status verified
Aug 2021
Primary completion
Jun 1, 2019
Completion
Jul 1, 2019

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide injection + Victoza
    Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.
  • Experimental: Victoza +Liraglutide injection
    Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle.

Primary Outcome Measure

Maximum (peak) plasma drug concentration(Cmax) [ Time Frame: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15. ]

Related Studies