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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
50 participants (actual)
Sponsor
Sunshine Lake Pharma Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
22 Jun 2020
Primary completion
20 Jul 2020
Completion
27 Nov 2020
First posted
24 Mar 2022
Last update posted
24 Mar 2022
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202021
  1. Ph 1

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

    NCT05294536

    22 Jun 2020 to 27 Nov 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Liraglutide injection,RD12014Drug
  • Liraglutide injection,VictozaDrug

Arms2

  • 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 outcomes2

Outcomes the sponsor listed as primary.

  1. Maximum (peak) plasma drug concentration(Cmax)

    Time frame · 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Registry description

    Maximum (peak) plasma drug concentration

  2. Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

    Time frame · 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Registry description

    The area under the plasma concentration curve from 0 to 72 h

Secondary outcomes(6)
  1. Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)

    Time frame · 0 hour(pre-dose,within 30mins) to infinity after administration

    Registry description

    The area under the plasma concentration curve from 0 to ∞

  2. Time to reach maximum plasma concentration following drug administration (Tmax)

    Time frame · 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Registry description

    Time to maximum concentration

  3. Elimination half-life (t1/2)

    Time frame · 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Registry description

    Elimination half-life

  4. Apparent total body clearance (CL/F)

    Time frame · 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Registry description

    Apparent total body clearance

  5. Apparent volume of distribution (Vd/F)

    Time frame · 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Registry description

    Apparent volume of distribution

  6. Adverse Event, Serious Adverse Event

    Time frame · Up to day 4 after the second dose.

    Registry description

    Monitor the safety indicators of subjects during the trial

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

5 results

A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects.

Zhou et al. 2022Clinical and translational sciencecited by 4

PMID 35871497PMC9579399DOI 10.1111/cts.13374PUB-35871497

Free to read · publisher termsCC BY-NC-ND5 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 1\. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol; * 2\. Aged between 18 and 45 years old of healthy male subjects ; * 3\. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ; * 4\. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities; * 5\. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance; Exclusion Criteria: * 1\. Have a history of fainting needles, fainting blood; * 2\. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening; * 3\. Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug; * 4\. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial; * 5\. Those who have been screened positive for drugs at screening; * 6\. Donated blood (\> 400 ml) within 3 months before taking the study drug; * 7\. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug. * 8\. Alcohol abuse (drinking 21 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine) or positive for breath alcohol test ; * 9\. Those who have been screened positive for drugs or have a history of drug abuse; * 10\. Known allergy to Liraglutide or any of the excipients of the formulation; * 11\. Those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;Or have a history or family history of multiple endocrine adenomatosis; * 12\. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug; * 13\. During the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods * 14\. Other cases judged by researchers to be unsuitable for selection.

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