NCT07097831已完成1 期
An Open-label, Single-arm, Fixed-sequence, Single-center Phase I Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年10月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Area under the curve from time 0 to time t (AUC0-t)
研究概览
简要总结
The study was designed to evaluate the pharmacokinetic effects of rosuvastatin calcium tablets after oral administration of HRS-1301 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, aged 18-55 years (inclusive).
- •At screening, 18.0 ≤ BMI ≤ 30 kg/m2 (inclusive), and body weight ≥ 50.0 kg and <90.0 kg for males and ≥ 45.0 kg and < 90.0 kg for females.
- •Physical examination, vital signs, electrocardiogram, chest X-ray /CT, abdominal ultrasound, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, thyroid function) were normal or abnormal but of no clinical significance.
- •The female subjects were not pregnant or lactating, and the results of pregnancy tests before the test were negative. Those who did not have unprotected sex within two weeks before screening; Female subjects of childbearing potential and men whose partners were women of childbearing age agreed to comply with relevant contraceptive requirements and had no sperm/egg donation plans.
- •Participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form.
排除标准
- •Previous medical history or current clinical diagnosis of cardiac, respiratory, endocrine, metabolic, cutaneous, infectious, malignant tumor, hematologic, neurological or psychiatric disorders, metabolic/functional disorders or other diseases.
- •Gastrointestinal, hepatic, or renal disease, as judged by the investigator, or other conditions known to affect the absorption, distribution, metabolism, and excretion of the drug or to impair adherence.
- •Patients with major trauma or surgery within 3 months before screening or planning to undergo surgery during the trial.
- •Patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergic to any drug, food), or known allergic to any ingredient in the study drug.
- •Participants who had used any drugs (including prescription drugs, over-the-counter drugs, herbal medicines, dietary supplements, etc., except regular vitamins and occasional acetaminophen) within 2 weeks before screening, or within 5 half-life periods of the drugs (whichever was longer).
- •Enrolled in a clinical trial of any drug or medical device within 3 months before screening or within 5 half-lives of the drug before screening, whichever is longer.
- •Individuals who have donated ≥ 400 mL blood within 4 weeks before screening, have severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 8 weeks before screening.
- •Persons who are scheduled to receive live (attenuated) vaccine within 4 weeks before screening or during the course of the trial.
- •Hepatitis B virus surface antigen, hepatitis C virus IgG antibody, anti-treponema pallidum antibody, human immunodeficiency virus antibody and antigen p24 positive during the screening period.
- •Those with positive alcohol breath test and/or drug abuse screening test at baseline.
- •A history of drug or substance abuse.
- •Potential difficulty in blood collection, with a history of syncope.
- •Investigators, research assistants, pharmacists, research coordinators, or others directly involved in the implementation of the protocol.
- •Any factors considered by the investigator to be unsuitable for participation in the trial.
- •Subjects voluntarily withdraw from the trial due to their own reasons.
研究组 & 干预措施
Treatment Group
Experimental
干预措施: HRS-1301 Tablets (Drug)
Treatment Group
Experimental
干预措施: Rosuvastatin Calcium Tablets (Drug)
结局指标
主要结局
Area under the curve from time 0 to time t (AUC0-t)
时间窗: 0 to anticipated 15 days.
Area under the curve from time 0 to time infinity (AUC0-∞)
时间窗: 0 to anticipated 15 days.
Maximum concentration (Cmax)
时间窗: 0 to anticipated 15 days.
次要结局
- Time to reach maximum concentration (Tmax)(0 to anticipated 15 days.)
- Half-life (t1/2)(0 to anticipated 15 days.)
- Apparent clearance (CL/F)(0 to anticipated 15 days.)
- Adverse events (AEs)(Baseline up to 19 days.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Rosuvastatin Calcium Tablets Under Fed ConditionsHealthy SubjectsNCT02962323Torrent Pharmaceuticals Limited48
已完成
1 期
Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.Healthy SubjectsNCT02962310Torrent Pharmaceuticals Limited48
已完成
1 期
A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy ParticipantsNCT06925854AstraZeneca12
已完成
3 期
A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic SyndromeMetabolic SyndromeDyslipidemiaNCT00240305AstraZeneca15
已完成
1 期
Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With FostamatinibRheumatoid ArthritisNCT01725230AstraZeneca42