NCT04764201已完成1 期
A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月16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
- 50
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.
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
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 kg/m^2 ≤ BMI < 28 kg/m^2, weight >60kg
- •90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <900 mmHg
- •agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
排除标准
- •A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
- •A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
- •A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
- •Positive results of serological tests
- •Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
- •Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days
- •Have drank more than 210 g/week of alcohol within 30 days before the screening date
- •Have smoked more than 10 bills/day within 30 days before the screening date
- •AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR < 50 mL/min/1.73m2, Prothrombin (INR) > 1.31 INR or aPTT > 39.7 sec
- •12-ECG QTc >450 ms
研究组 & 干预措施
Sequence 1
Other
Period 1: HGP2001, Period 2: HIP2001
干预措施: HIP2001 (Drug)
Sequence 1
Other
Period 1: HGP2001, Period 2: HIP2001
干预措施: HGP2001 (Drug)
Sequence 2
Other
Period 1: HIP2001, Period 2: HGP2001
干预措施: HIP2001 (Drug)
Sequence 2
Other
Period 1: HIP2001, Period 2: HGP2001
干预措施: HGP2001 (Drug)
结局指标
主要结局
AUCt
时间窗: 0~48 hours
Pharmacokinetic evaluation
Cmax
时间窗: 0~48 hours
Pharmacokinetic evaluation
次要结局
- CL/F(0~48 hours)
- AUCinf(0~48 hours)
- Tmax(0~48 hours)
- t1/2(0~48 hours)
- Vd/F(0~48 hours)
研究者
研究点 (1)
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