NCT07181343已完成1 期
A Study to Evaluate the Pharmacokinetics of Drospirenone and Ethinyl Estradiol Tablets (Yasmin®) When Co-administered With HS-10374 Tablets
Hansoh BioMedical R&D Company1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年5月28日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Cmax
研究概览
简要总结
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study to evaluate Drug-Drug Interaction Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets (Yasmin®)
详细描述
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study. On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets (containing Drospirenone 3 mg and Ethinylestradiol 0.03 mg) under fasting conditions. From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg once daily under fasting conditions. Both drugs should be administered with approximately 240 mL of water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants who sign the informed consent form before the trial, fully understand the trial content, procedures, and potential adverse reactions, and voluntarily commit to complying with all trial requirements.
- •Healthy female participants aged 18 to 40 years (inclusive), with age calculated based on the date of signing the informed consent.
- •Participants weighing ≥45 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
- •Participants who agree to abstain from conception/donation of oocytes and practice complete abstinence from signing the informed consent until 40 days after the last dose.
排除标准
- •Participants with clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests, abdominal ultrasound, gynecological color ultrasound, or breast color Doppler ultrasound, as judged by the investigator.
- •Positive results for any of the following during screening: Hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody.
- •Screening values exceeding 1.5×ULN for ALT, AST, or creatine kinase (CK), with clinical significance per investigator assessment.
- •Screening serum creatinine >1×ULN, judged clinically significant by the investigator.
- •QT interval prolongation on 12-lead ECG during screening (QTcF ≥470 ms).
- •History of myopathy or rhabdomyolysis.
- •Severe pre-existing or current diseases affecting the nervous, psychiatric, digestive, circulatory, respiratory, urinary, cardiovascular, or immune systems-or any newly diagnosed condition prior to dosing-deemed by the investigator to contraindicate participation; including history of gastrointestinal disorders (e.g., gastric ulcer, reflux esophagitis).
- •History of tuberculosis (TB).
- •Current or previous history of: Venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism), Cerebrovascular disorders, Coronary artery disease, hypertension, Thrombogenic cardiac valvulopathy or rhythm disorders (e.g., subacute bacterial endocarditis with valvular disease, atrial fibrillation), Hereditary/acquired hypercoagulable states (e.g., Factor V Leiden mutation family history), Diabetes with vascular complications, Headaches with focal neurological symptoms, Migraine (with or without aura), Cholestatic jaundice and/or pruritus during prior hormone therapy.
- •Current or previous renal impairment or adrenal insufficiency.
- •Undiagnosed abnormal uterine/vaginal bleeding.
- •Current or previous estrogen/progestin-sensitive cancers (e.g., breast cancer).
- •Benign/malignant liver tumors or severe liver disease with safety risks per investigator judgment.
- •Active/latent TB infection during screening, assessed by: T-SPOT.TB (interferon-gamma release assay),Chest X-ray. Exclusion if: Chest X-ray shows TB lesions OR T-SPOT.TB positive.
- •Severe infections ≤30 days before screening (e.g., cellulitis, pneumonia, sepsis) OR herpes zoster within 3 months prior.
- •Participants who have undergone surgery affecting drug absorption, distribution, metabolism, or excretion, deemed ineligible by the investigator.
- •Individuals with a history of hypersensitivity or allergic predisposition (e.g., to pollen, ≥2 drugs/foods), or known allergy to: Active ingredients/excipients of the investigational products (Drospirenone and Ethinylestradiol Tablets & HS-10374 Tablets), Other Janus Kinase (JAK) inhibitors.
- •Participation in any other clinical trial involving investigational drugs/devices within 3 months prior to screening .
- •Blood donation or significant blood loss (>400 mL) within 3 months before screening, or plans to donate blood during the trial or within 1 month after completion .
- •Ingestion of grapefruit or grapefruit products within 48 hours before the first dose of investigational products .
- •Excessive consumption of tea, coffee, or caffeine-containing beverages (>8 cups/day on average; 1 cup=200 mL) within 3 months prior to screening .
- •Participants who smoked ≥1 cigarette/day within 3 months before screening, were unable to quit tobacco products during the trial, or tested positive for nicotine.
- •Participants who drank alcohol frequently (>14 units/week, 1 unit =14 g alcohol) within 3 months before screening, couldn't stop using alcohol during the trial, or tested positive for alcohol in breath tests.
- •Participants who used alcohol-containing products within 24 h before taking the test drug or had a positive alcohol breath test result.
- •Participants with a history of drug abuse, dependence, or illicit drug use within 5 years before screening, or tested positive for drug abuse in urine tests.
- •Participants who used drugs affecting liver metabolic enzymes (CYP3A, CYP1A2, CYP2D6, CYP2B6) or P-gp/BCRP activity, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, or hormonal drugs within 30 days before the first test drug dose.
- •Participants who used long-acting estrogen/progestin injectables or implants within 12 months before the first dose, or transdermal contraceptives or intrauterine devices with hormones within 3 months before enrollment.
- •Participants who used drugs altering gastric pH (e.g., rebamipide, omeprazole, lansoprazole, ranitidine, aluminum hydroxide) within 30 days before screening.
- •Participants who used prescription drugs, OTC drugs, herbs, or health products (excluding local-acting topical agents) within 14 days before screening.
- •Participants who used vaccines within 14 days before screening or planned to use them during or within two weeks after the trial.
- •Participants who tested positive for pregnancy or were breastfeeding at screening.
- •Participants who had unprotected sex within 14 days before screening.
- •Participants unable to tolerate venipuncture/indwelling needle blood collection or with a history of fainting at the sight of blood.
- •Participants unlikely to complete the trial for other reasons or deemed unsuitable by the investigator.
研究组 & 干预措施
HS-10374 + Drospirenone and Ethinyl Estradiol
Experimental
干预措施: HS-10374 tablets (Drug)
HS-10374 + Drospirenone and Ethinyl Estradiol
Experimental
干预措施: Drospirenone and Ethinyl Estradiol tablets (Drug)
结局指标
主要结局
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Cmax
时间窗: up to Day 20
Maximum concentration
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-t
时间窗: up to Day 20
Area under the plasma concentration-time curve fom time 0 to last time of quantifiable concentration
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-24 h
时间窗: up to Day 20
Area under the plasma concentration-time curve fom time 0 to 24 h of quantifiable concentration
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-∞
时间窗: up to Day 20
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time
次要结局
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Vz/F(up to Day 20)
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-t(up to Day 20)
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-∞(up to Day 20)
- Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing：Cmax(up to Day 20)
- Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cmin(up to Day 20)
- Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cav(up to Day 20)
- Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: AUC0-24h(up to Day 20)
- Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Tmax(up to Day 20)
- Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: t1/2z(up to Day 20)
- Evaluation of the safety after single oral administration of HS-10374 tablets and drospirenone/ethinylestradiol tablets in healthy participants(through study completion, an average of 1 month)
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Tmax(up to Day 20)
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: t1/2z(up to Day 20)
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: λz(up to Day 20)
- Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: CLz/F(up to Day 20)
研究者
研究点 (1)
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