A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Phase 1 Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930, in Healthy Male Subjects
概览
- 阶段
- 1 期
- 干预措施
- D565
- 疾病 / 适应症
- Glaucoma
- 发起方
- Chong Kun Dang Pharmaceutical
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax,ss of D930(Sequence1)
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration of D565 and D930, in healthy male subjects
详细描述
To healthy male subjects of thirty-two (32), Investigational products are administered following treatments in each period
研究者
入排标准
入选标准
- •Healthy adults volunteers aged between 19 and 55 years old at the time of screening
- •Weight ≥ 55 kg, Calculated Body Mass Index(BMI) of 18.0 to 30.0 kg/m2
- •\* BMI = Weight(kg)/ Height(m)2
- •Individuals who sign an informed consent form and decide to participate in the study after being fully informed of the study prior to participation
- •Individuals who are suitable as a subject for this study at the discretion of the researcher as a result of screening tests such as examination, laboratory tests and questionnaires
排除标准
- •Individuals who have other clinically significant cardiovascular system, respiratory system, liver, renal, nervous system, endocrine system, blood-oncology, psychiatric disorders, urinary system or ophthalmic diseases or have a history
- •Individuals who satisfy the following items during the interview or examination
- •Individuals with a history of or sign or symptoms of a disease of the visual system
- •Individuals who had an ophthalmic surgery including for refractive correction surgery such as LASIK.
- •Individuals with corrected visual acuity of 20/40 or less
- •Individuals who have experienced side effects after wearing contact lenses or who have worn contact lenses within the last month
- •Individuals who have more than 21mmHg or less than 10mmHg on either side of the intraocular pressure test
- •Individuals who show abnormal findings in other ophthalmic examinations
- •Individuals who have a history of hypersensitivity to the active ingredient and component of the investigational drug, or to the drug in the same class as the active ingredient
- •Individuals with sitting systolic blood pressure ≥ 140 mmHg or ≤ 80 mmHg or sitting diastolic blood pressure ≥ 90 mmHg or ≤ 45 mmHg
研究组 & 干预措施
Sequence 2
1. Period 1: D930 91days 2. Period 2: D565+D930 7days
干预措施: D565
Sequence 2
1. Period 1: D930 91days 2. Period 2: D565+D930 7days
干预措施: D930
Sequence 1
1. Period 1: D565 7days 2. Period 2: D565+D930 91days
干预措施: D565
Sequence 1
1. Period 1: D565 7days 2. Period 2: D565+D930 91days
干预措施: D930
结局指标
主要结局
Cmax,ss of D930(Sequence1)
时间窗: 8day 0hour ~ 99day 0hour
The maximum D930 concentration between 0 and τ at steady state
AUCtau,ss of D565(Sequence1)
时间窗: 1day 0hour ~ 99day 0hour
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
AUCtau,ss of D565(Sequence2)
时间窗: 96day 0hour ~ 99day 0hour
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
AUCtau,ss of D930(Sequence2)
时间窗: 1day 0hour ~ 99day 0hour
Area under the D930 concentration in blood-time curve from 0 to τ at steady
AUCtau,ss of D930(Sequence1)
时间窗: 8day 0hour ~ 99day 0hour
Area under the D930 concentration in blood-time curve from 0 to τ at steady
Cmax,ss of D565(Sequence1)
时间窗: 1day 0hour ~ 99day 0hour
The maximum D565 concentration between 0 and τ at steady state
Cmax,ss of D565(Sequence2)
时间窗: 96day 0hour ~ 99day 0hour
The maximum D565 concentration between 0 and τ at steady state
Cmax,ss of D930(Sequence2)
时间窗: 1day 0hour ~ 99day 0hour
The maximum D930 concentration between 0 and τ at steady state