An Open-label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- [Part A] Cmax,ss of BR1015-1
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetic interactions (Drug-Drug interaction) and safety between "BR1015-1" and "BR1015-2" in healthy volunteers.
详细描述
*Study Objective: After repeated administration of BR1015-1 and BR1015-2 for healthy volunteers, the pharmacokinetic interactions and safety are evaluated.
*Investigational Product (and regimen)
- BR1015-1: Administration of BR1015-1 60 mg once a day for 5 days
- BR1015-2: Administration of BR1015-2 1.5 mg once a day for 5 days
- BR1015-1+BR1015-2: Co-administration of BR1015-1 60 mg and BR1015-2 1.5 mg once a day for 5 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are given sufficient explanations about the trial objectives and contents as well as properties of investigational drugs before participating in the trial, and will voluntarily express their consent by signing an IRB-approved written consent to participate in the trial.
- •Healthy adults aged 19 to 55 years at screening.
- •The subject's weight is 50 kg or more for males, 45 kg or more for females, and body mass index (BMI) is 18.0 or more but 30.0 kg/m2 or less.
排除标准
- •Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients and other ingredients of investigational products.
- •Those who have history of clinically significant diseases including allergy reaction to Yellow No. 5 (Sunset Yellow FCF).
- •Those who have a history of clinically significant diseases related to liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, cardiovascular system (including orthostatic hypotension), etc.
- •Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) and operations that may influence the absorption of investigational drugs. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
- •Those with abnormal findings from the screening tests (medical interview, vital signs, electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to have clinical significance.
- •Those who are positive to HBsAg, HCV Ab, HIV Ab, VDRL tests at screening.
- •Those with any of the following results at screening:
- •AST or ALT > twice the upper limit of normal range
- •T. bilirubin > twice the upper limit of normal range
- •Estimated glomerular filtration rate (e-GFR) < 60 mL/min/1.73m2 (CKD-EPI method used)
- •Na > 150 mEq/L or <130 mEq/L
- •K > 5.5 mEq/L or <3.0 mEq/L
- •Those with systolic blood pressure > 160 mmHg or < 110 mmHg, or diastolic blood pressure > 100 mmHg or < 70 mmHg from vital signs at screening.
- •Others who are judged to be ineligible to participate in the trial by the investigator.
研究组 & 干预措施
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
A total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3.
- Period 1(BR1015-1): BR1015-1(Fimasartan 60mg) - 1 tablet QD, five-day repeated-dose
- Period 2(BR1015-2): BR1015-2(Indapamide 1.5mg) - 1 tablet QD, five-day repeated-dose
- Period 3(BR1015-1 + BR1015-2): BR1015-1 (Fimasartan 60mg) 1 tablet + BR1015-2 (Indapamide 1.5mg) 1 tablet QD, five-day repeated-dose
- Washout period between Period 1 and Period 2: five days
- Washout period between Period 2 and Period 3: two days
干预措施: BR1015-1 (Drug)
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
A total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3.
- Period 1(BR1015-1): BR1015-1(Fimasartan 60mg) - 1 tablet QD, five-day repeated-dose
- Period 2(BR1015-2): BR1015-2(Indapamide 1.5mg) - 1 tablet QD, five-day repeated-dose
- Period 3(BR1015-1 + BR1015-2): BR1015-1 (Fimasartan 60mg) 1 tablet + BR1015-2 (Indapamide 1.5mg) 1 tablet QD, five-day repeated-dose
- Washout period between Period 1 and Period 2: five days
- Washout period between Period 2 and Period 3: two days
干预措施: BR1015-2 (Drug)
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
A total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3.
- Period 1(BR1015-1): BR1015-1(Fimasartan 60mg) - 1 tablet QD, five-day repeated-dose
- Period 2(BR1015-2): BR1015-2(Indapamide 1.5mg) - 1 tablet QD, five-day repeated-dose
- Period 3(BR1015-1 + BR1015-2): BR1015-1 (Fimasartan 60mg) 1 tablet + BR1015-2 (Indapamide 1.5mg) 1 tablet QD, five-day repeated-dose
- Washout period between Period 1 and Period 2: five days
- Washout period between Period 2 and Period 3: two days
干预措施: BR1015-1 + BR1015-2 (Drug)
结局指标
主要结局
[Part A] Cmax,ss of BR1015-1
时间窗: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-1 at steady state (Cmax,ss).
[Part B] Cmax,ss of BR1015-2
时间窗: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-2 at steady state (Cmax,ss).
[Part A] AUCtau of BR1015-1
时间窗: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-1 at steady state. (AUCtau,ss)
[Part B] AUCtau of BR1015-2
时间窗: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-2 at steady state. (AUCtau,ss)
次要结局
- [Part A] AUClast of BR1015-1(0~48 hour after administration)
- [Part B] AUClast of BR1015-2(0~48 hour after administration)
- [Part A] AUCinf of BR1015-1(0~48 hour after administration)
- [Part B] AUCinf of BR1015-2(0~48 hour after administration)
- [Part B] Tmax of BR1015-2(0~24 hour after administration)
- [Part A] Tmax of BR1015-1(0~24 hour after administration)
- [Part A] t1/2 of BR1015-1(0~48 hour after administration)
- [Part B] t1/2 of BR1015-2(0~48 hour after administration)