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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

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

China

Start
31 May 2022
Primary completion
2 Jul 2022
Completion
8 Jul 2022
First posted
14 Jul 2022
Last update posted
25 Aug 2022
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023
  1. Ph 1

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

    NCT05459285

    31 May 2022 to 8 Jul 2022

Registry summary

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

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

Interventions

  • 14028 injectionBiological
  • dulaglutide injectionBiological

Arms2

  • Experimental

    14028 injection

    Subjects receive 14028 injection in the study, 0.75mg, once

  • Active comparator

    dulaglutide injection (TRULICITY®)

    Subjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

    Registry description

    Maximum (peak) plasma drug concentration

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

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

    Registry description

    The area under the plasma concentration curve from 0 to ∞

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

    Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

    Registry description

    The area under the plasma concentration curve from 0 to 384 h

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

    Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

    Registry description

    Time to maximum concentration

  3. Elimination half-life (t1/2)

    Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

    Registry description

    Elimination half-life

  4. Apparent total body clearance (CL/F)

    Time frame · 0 hour (pre-dose,within 30mins) to 384 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 384 hours after administration

    Registry description

    Apparent volume of distribution

  6. Elimination constants (λz)

    Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

    Registry description

    Elimination constants

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

Studies5

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2024

8 results

A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity®) in healthy Chinese subjects.

Gao et al. 2024Clinical and translational sciencecited by 2

PMID 38651744PMC11036873DOI 10.1111/cts.13775PUB-38651744

Free to read · publisher termsCC BY-NC8 results

Indexing hint: Randomized controlled trial · 2017

11 results

No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide.

de la Peña et al. 2017Clinical pharmacokineticscited by 22

PMID 28357715DOI 10.1007/s40262-017-0531-7PUB-28357715

Full text at the publisher11 results

Indexing hint: Clinical trial · 2016

10 results

Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials.

Geiser et al. 2016Clinical pharmacokineticscited by 81

PMID 26507721DOI 10.1007/s40262-015-0338-3PUB-26507721

Full text at the publisher10 results

Indexing hint: Randomized controlled trial · 2011

11 results

A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes.

Barrington et al. 2011Diabetes, obesity & metabolismcited by 91

PMID 21251178DOI 10.1111/j.1463-1326.2011.01364.xPUB-21251178

Full text at the publisher11 results

Indexing hint: Randomized controlled trial · 2011

10 results

LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects.

Barrington et al. 2011Diabetes, obesity & metabolismcited by 59

PMID 21251179DOI 10.1111/j.1463-1326.2011.01365.xPUB-21251179

Full text at the publisher10 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. Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily 2. Healthy male subjects aged 18 to 45 (including the critical value) 3. Weight \> or = 50 kg, and 19.0 kg/m2 \< or = BMI (body mass index) \< or = 28.0 kg/m2 4. Vital signs, physical examination, laboratory examination, electrocardiogram, thyroid color Doppler ultrasound, abdominal color Doppler ultrasound and chest X-ray (anteroposterior) and other test results during screening are normal or have no clinical significance as judged by the investigator 5. Subjects agree to use effective contraceptive methods from signing the informed consent form to the end of the trial drug use within 3 months, and there is no sperm donation plan. Exclusion Criteria: 1. The investigator judges that the subjects have the following clinically significant diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) 2. Have a medical or family history of medullary thyroid cancer (grandparents, parents, brothers and sisters), or a genetic disease that lead to medullary thyroid cancer; or a history or family history of multiple endocrine neoplasia syndrome type 2 3. Past or current history of pancreatitis (chronic or acute pancreatitis) 4. Past or current history of habitual constipation or intestinal obstruction 5. Clinically significant history of drug allergy or specific allergic disease (asthma, urticaria) or known allergy to the investigational drug and any component or related excipient components 6. Those who have difficulty with venous blood collection, a history of needle sickness, haemorrhage, or a known tendency to severe bleeding 7. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIV), and Treponema pallidum antibody (TPAb) 8. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products (except vitamin supplements) within 2 weeks before the first dose 9. Those who have a history of vaccination with live attenuated vaccine within 3 months before screening or a history of vaccination with inactivated vaccine within 1 month before screening 10. Those who have previously received dulaglutide or any other glucagon-like peptide-1 (GLP-1) analog 11. Those who donated blood or lost blood \> or = 400 mL within 3 months before screening, or those who plan to donate blood 12. Those who smoked more than 5 cigarettes per day within 3 months before screening or who could not give up smoking during the period from signing the informed consent to the subjects leaving the group 13. Those who have a history of alcohol abuse, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) , or those who have a positive alcohol breath test during the screening period 14. Those who have a history of drug abuse or poison use within 2 years before screening, or those who have a positive test results for urine drug abuse screening during the screening period 15. Participated in other clinical trials within 3 months before screening (subjects who are not randomized or not receiving treatment withdraw from the study before treatment, they can be enrolled in this study) 16. Acute illness or concomitant medication occurred from the time of signing the informed consent to the first administration 17. Those who have special requirements for diet and cannot obey the unified diet 18. Others judged by the investigator to be unsuitable to participate in this trial 19. Subjects who may not be able to complete this trial for other reasons

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