Relative Bioavailability of Two Different Vicadrostat/ Empagliflozin Combinations and Investigation of the Effect of Food on the Pharmacokinetics of a Vicadrostat/ Empagliflozin Combination in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Three- Way Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum measured concentration of the analyte in plasma (C max)
研究概览
简要总结
To investigate the relative bioavailability of two different vicadrostat/empagliflozin combinations. Additionally, the trial investigates the effect of food on the pharmacokinetics of the vicadrostat/empagliflozin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •Body Mass Index (BMI) of 18.5 to 29.9 kg / m^2 (inclusive)
- •Signed and dated written informed consent in accordance with Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •For female trial participants: Female trial participants who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
- •Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
- •Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
- •Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) plus condom
- •Sexually abstinent (if refraining from heterosexual intercourse is the preferred and usual lifestyle of the subject).
- •A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
- •Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation)
- •Postmenopausal, defined as no menses for 1 year without an alternative medical cause.
排除标准
- •Any finding in the medical examination (including Blood pressure (BP) Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 105 to 140 mmHg, diastolic blood pressure outside the range of 65 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
研究组 & 干预措施
R -T1 -T2
R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed
干预措施: vicadrostat / empagliflozin combination 1 (Drug)
R -T1 -T2
R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed
干预措施: vicadrostat / empagliflozin 2 (Drug)
T1 - R - T2
R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed
干预措施: vicadrostat / empagliflozin combination 1 (Drug)
T1 - R - T2
R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed
干预措施: vicadrostat / empagliflozin 2 (Drug)
结局指标
主要结局
Maximum measured concentration of the analyte in plasma (C max)
时间窗: Up to 4 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
时间窗: Up to 4 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)(Up to 4 days)