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A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

NCT05459285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-08-25

No results posted yet for this study

Summary

To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects

Conditions

Interventions

BIOLOGICAL

14028 injection

14028 injection, single dose, s.c. injection

BIOLOGICAL

dulaglutide injection

dulaglutide injection(TRULICITY®), single dose, s.c. injection

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jie Hou, doctor · Peking University Care Luzhong Hospital

  • Hong Wang, bachelor · Peking University Care Luzhong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-07-02
Completion
2022-07-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05459285 on ClinicalTrials.gov