Randomized, 2-way Crossover, Pharmacokinetic Study of Lysteda (Xanodyne Modified-Immediate Release Tranexamic Acid) Tablets at 2 Doses in Fasting Adolescent Females With Evidence of Heavy Menstrual Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Concentrations Level (Cmax)
研究概览
简要总结
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy menstrual bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy non-smoking (for at least 3 months) adolescent females 12-16 years of age with a history of at least 1 year of cyclic heavy menstrual bleeding (HMB)
- •Subjects must report regularly occurring menstrual periods ≤10 days in duration, with 21-45 days from the start of one period to the start of the next menstrual period
- •Diagnosis of HMB based on the medical judgment of the Principal Investigator and will include the following criteria:
- •Laboratory (including a bleeding disorders work-up) and Physical Findings;
- •Limitations in Activities of Daily Living (ADL);
- •Soiling, Staining and Clotting;
- •Sanitary product usage and extent of MBL using a patient reported pictorial blood assessment chart (PBAC).
- •Subjects should either be sexually inactive (abstinent) or be using one of the following acceptable birth control methods and agree to continue its use throughout the study:
- •copper intrauterine device (IUD) in place for at least 3 months;
- •barrier methods (condom, diaphragm) with spermicide for at least 1 month prior to the first dose and throughout the study.
- •Negative pregnancy test results
- •Subject's legally authorized representative (e.g., parent, guardian) must voluntarily sign a parental permission/informed consent form (ICF), and the subject must sign an assent, before the conduct of any study procedure
排除标准
- •Breast-feeding, or a history of abortion in the last 6 months
- •Known bleeding or coagulation disorders based on medical history and/or laboratory results
- •Known systemic hematologic diseases (e.g., all types of sickle-cell disease, thalassemia of all types, multiple myeloma, hemolytic anemia)
- •Clinical evidence of any significant chronic illness, including cardiovascular, renal, neurologic, hepatic, endocrine, gastric, central nervous system disease, any psychiatric illness which could affect the efficacy or safety of study medication
- •Subjects treated with systemic steroids in the last 1 month or hormonal treatment in the last 3 months
- •A history or presence of any drug abuse or alcohol abuse within the last 1 year
- •History of subarachnoid hemorrhage.
- •Active thromboembolic disease; history of thrombosis or thromboembolism, including retinal vein or artery occlusion; an intrinsic risk of thrombosis or thromboembolism
- •Use of vaginal hormone products (rings, creams, and gels) within 4 weeks prior to screening. Use of oral estrogen-, progestin-, or selective estrogen receptor within 8 weeks prior to screening. Use of Lupron (3-month depot injection), estrogen pellet, or long-acting progestin injectables within 6 months prior to screening
- •Subjects whose sitting blood pressure is less than 90/60 mmHg at screening
- •Subjects whose pulse is lower than 50 b.p.m. at screening
- •Subjects whose PR interval is >200 msec at screening and prior to dosing
- •Subjects whose QTc interval >450 msec
- •Subjects with positive tests for hepatitis B, C, or human immunodeficiency virus (HIV)
研究组 & 干预措施
0.65 g / 1.3 g tranexamic acid
Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
干预措施: tranexamic acid (Drug)
1.3 g / 0.65 g tranexamic acid
Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
干预措施: tranexamic acid (Drug)
结局指标
主要结局
Maximum Concentrations Level (Cmax)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Cmax is the maximum measured plasma concentration over the time-span specified.
Dose-normalized Maximum Concentrations Level (Cmax)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Cmax is the maximum measured plasma concentration over the time-span specified and normalized to the 1.3 g dose.
Time to Maximum Concentration Level (Tmax)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.
Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.
Dose Normalized Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration normalized to the 1.3 g dose.
Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
The area under the plasma concentration versus time curve from time 0 to infinity. AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Dose Normalized Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Dose-normalized AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, normalized to the 1.3 g dose.
The Ratio of AUC0-t to AUCinf
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Comparison of AUC0-t to AUCinf by creating a ratio.
Elimination Half-life (t ½)
时间窗: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Apparent first-order terminal elimination half life
次要结局
- Participants With Treatment-emergent Adverse Events (TEAEs)(Day 1 up to week 4)