NCT03234244已完成1 期
A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Drug-Drug Interaction
研究概览
简要总结
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight 50kg ≤ / BMI=18~29kg/㎡
- •A person who is determined to be eligible for the test through a physical examination or an interview
- •Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test
排除标准
- •Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
- •Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
- •Any person who shows any of the following results in the screening test
- •AST or ALT > 2 times upper limit of normal range
- •Total Bilirubin > 2.0mg/dL
- •Glomerular filtration rate (eGFR) < 60mL / min/ 1.7㎡
- •Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
- •Those who have a history of drug abuse or who have a positive urine drug test
研究组 & 干预措施
Bazedoxifene 20mg
Active Comparator
Subjects will take bazedoxifene 1 Tablet.
干预措施: Bazedoxifene 20 mg (Drug)
Cholecalciferol
Active Comparator
Subjects will take Cholecalciferol 2 Tablets.
干预措施: Cholecalciferol (Drug)
Bazedoxifene 20mg and Cholecalciferol
Experimental
Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
干预措施: Bazedoxifene 20mg and Cholecalciferol (Drug)
结局指标
主要结局
Drug-Drug Interaction
时间窗: Day 1~Day 56
To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.
次要结局
- Pharmacokinetic Assessment(Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour)
研究者
研究点 (1)
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