A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

Sponsor
Sunshine Lake Pharma Co., Ltd.
Study ID
NCT05294536
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.

Key Dates

Start date
Jun 22, 2020
Status verified
Mar 2022
Primary completion
Jul 20, 2020
Completion
Nov 27, 2020

Study Design

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

Arms

  • Experimental: Liraglutide injection (RD12014)+ Victoza
    Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.
  • Experimental: Victoza + Liraglutide injection (RD12014)
    Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.

Primary Outcome Measure

Maximum (peak) plasma drug concentration(Cmax) [ Time Frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration ]

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