- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07479641
건강한 참가자를 대상으로 한 HRS-1893 정제 두 제형의 생물학적 동등성 연구
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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-
Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100730
- Beijing Hospital
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects aged 18 to 55 years (inclusive), regardless of gender;
- Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥ 50.0 kg and < 90.0 kg for men, and ≥ 45.0 kg and < 90.0 kg for women;
- No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment;
- No clinically significant abnormalities on the 12-lead ECG;
- The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
Exclusion Criteria:
- Subjects with suspected hypersensitivity to the investigational drug or any excipient;
- The subject has a history of syncope;
- Exclusion due to blood pressure: Systolic Blood Pressure (SBP) >140 mmHg or <90 mmHg; OR Diastolic Blood Pressure (DBP) >90 mmHg or <60 mmHg, as determined by the investigator to be clinically significant;
- History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption;
- A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag);
- Subjects who meet any of the following criteria will be excluded: a. Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening; b. Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits); c. Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration; d. Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse;
- History of substance abuse;
- Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded;
- Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.
공부 계획
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: HRS-1893 시험 제형군
|
Test formulation of HRS-1893 tablet, oral. |
|
실험적: HRS-1893 참조 제형 그룹
|
Reference formulation of HRS-1893 tablet, oral. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Peak concentration (Cmax).
기간: From Day 1 to Day 17.
|
Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Area under the plasma concentration - time curve from Time 0 to the last quantifiable time point (AUC0-t).
기간: From Day 1 to Day 17.
|
Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Area under the plasma concentration - time curve from Time 0 to infinity (AUC0-∞).
기간: From Day 1 to Day 17.
|
Primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to peak concentration (Tmax).
기간: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Elimination half-life (t1/2).
기간: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Apparent clearance (CL/F).
기간: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Apparent volume of distribution (Vz/F).
기간: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Incidence and severity of any adverse events (AEs).
기간: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
|
12-Lead Electrocardiogram (ECG) QT Interval.
기간: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
|
Transthoracic echocardiogram (TTE) results.
기간: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
|
Vital signs results - blood pressure.
기간: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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