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Human Bioequivalence Test of Liraglutide Injection

2021년 8월 30일 업데이트: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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.

연구 개요

연구 유형

중재적

등록 (실제)

28

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Jilin
      • Changchun, Jilin, 중국, 130021
        • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions;
  2. Able to complete the study according to the requirements of protocol;
  3. Aged between 18 and 60 years old, both men and women;
  4. Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value);
  5. No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
  6. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
  7. The female blood pregnancy test is not pregnant, and the subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before administration to at least 3 months after the last use of the study drug. See the appendix for specific contraceptive measures.

Exclusion Criteria:

  1. Previous disease of the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator determines may affect drug metabolism or safety;
  2. Have a history of fainting needles, fainting blood;
  3. Known allergy to Liraglutide and its metabolites or any of the excipients of the formulation;
  4. Those who smoked more than 5 cigarettes per day during the 3 months before the trial.
  5. History of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine);
  6. Donated blood or lost a lot of blood (> 450 ml) within 2 months before taking the study drug ;
  7. Have taken any drug that changes liver enzyme activity 28 days before taking the study drug (such as liver drug enzyme inhibitor chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver drug enzyme inducer barbital Drugs, carbamazepine, rifampicin, dexamethasone, etc.);
  8. Have taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug;
  9. During the trial it is necessary to use tobacco, alcohol, and caffeine-containing drinks, or certain foods that may affect metabolism (such as grapefruit, grapefruit juice, etc.), or major changes in diet or exercise habits before the test, or other effects that affect drug absorption, Factors such as distribution, metabolism, excretion, etc;
  10. Have taken the study drug or participated in the drug clinical trial within 2 months before taking the study drug;
  11. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
  12. Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or during the test;
  13. Those who have been screened positive for drugs or have a history of drug abuse in the past five years or have used drugs in the 3 months before the trial;
  14. Blood collection is difficult or cannot tolerate venipuncture blood collection;
  15. Acute illness during the screening phase or before study medication;
  16. The subject is unable or can not comply with ward management regulations;
  17. The subject is unable to complete the study due to personal reasons;
  18. Other cases judged by researchers to be unsuitable for selection.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Liraglutide injection + Victoza
Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.
Human glucagon-like peptides-1 analogue
Human glucagon-like peptides-1 analogue
실험적: Victoza +Liraglutide injection
Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle.
Human glucagon-like peptides-1 analogue
Human glucagon-like peptides-1 analogue

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum (peak) plasma drug concentration(Cmax)
기간: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Maximum (peak) plasma drug concentration
0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
기간: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Time to maximum concentration
0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
기간: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
The area under the plasma concentration curve from 0 to infinity
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Terminal disposition rate constant/terminal rate constant (λz)
기간: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent end elimination rate constant
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Elimination half-life (t1/2)
기간: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
The time required for the highest concentration of the drug in plasma to decrease by half
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent total clearance of the drug from plasma after oral administration (CL/F)
기간: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent total body clearance
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent volume of distribution after non-intravenous administration (Vd/F)
기간: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent volume of distribution
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Bioavailability (systemic availability of the administered dose)
기간: 0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
Relative bioavailability
0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
Adverse Event, Serious Adverse Event and Drug Combination
기간: up to day 15
Monitor the safety indicators of subjects during the trial
up to day 15

2차 결과 측정

결과 측정
측정값 설명
기간
body temperature
기간: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
abnormal body temperature
1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
pulse
기간: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
abnormal pulse
1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
blood pressure
기간: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
abnormal blood pressure
1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
clinical symptoms
기간: From the screening period to day 18 after the first administration
Any discomfort spontaneously reported by the subject
From the screening period to day 18 after the first administration
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
기간: From the screening period to day 18 after the first administration
Monitor the safety indicators of subjects during the trial,For example: skin, mucous membrane, head (head, eyes, ears, nose, mouth), neck, chest (chest, breast, lung, heart), abdomen (liver, gallbladder, spleen, kidney, bladder), spine, limbs, nervous system, lymph nodes, etc,and calculate the Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
From the screening period to day 18 after the first administration
The Number of participants with abnormal laboratory examinations
기간: From the screening period to day 18 after the first administration
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
From the screening period to day 18 after the first administration

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 5월 21일

기본 완료 (실제)

2019년 6월 1일

연구 완료 (실제)

2019년 7월 1일

연구 등록 날짜

최초 제출

2021년 8월 24일

QC 기준을 충족하는 최초 제출

2021년 8월 30일

처음 게시됨 (실제)

2021년 8월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 8월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 8월 30일

마지막으로 확인됨

2021년 8월 1일

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제2형 당뇨병에 대한 임상 시험

Liraglutide injection에 대한 임상 시험

3
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