A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability of BR4002 Comparing to BR4002-1 in Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variables -Area Under the concentration-time Curve from time 0 to t after single dosing(AUCt) of BR4002 and BR4002-1
研究概览
简要总结
This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.
详细描述
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Healthy adults aged ≥ 19 and ≤ 55 years at screening
- Body weight of ≥ 50 kg with calculated body mass index (BMI) of ≥ 18.0 to ≤ 29.0 kg/m2
- Determined eligible based on the results of physical examination and investigator questioning conducted according to this protocol. That is, absence of congenital or chronic disease, and absence of pathological symptoms or findings based on medical examination in the last 3 years.
- Determined eligible based on the results of the laboratory tests and electrocardiogram (ECG) conducted according to this protocol
- Voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a detailed explanation on this study and fully understanding the information
排除标准
- Hypersensitivity to, or history of clinically significant hypersensitivity to donepezil hydrochloride, piperidine derivatives or any ingredients of piperidine derivatives, or other drugs (aspirin, antibiotics, etc.)
- Hereditary disorders including galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption
- History of heart disease such as sinus node syndrome, intra-atrial conduction disturbance or atrioventricular junctional conduction disturbance
- Ongoing administration of non-steroidal anti-inflammatory drugs or history of peptic ulcer
- History of asthma or obstructive pulmonary disease
- Extrapyramidal disorder
- Psychotic disorders or drug addiction
- Presence or prior history of a gastrointestinal disorder or prior history of gastrointestinal surgery or skin graft that may affect the absorption of the IP
- Presence or prior history of clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematological and oncological, psychotic, or urinary disease
- Clinically significant hypotension (systolic blood pressure < 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
- Any of the following results from screening tests:
- AST or ALT > 2 times the upper limit of normal
- Total bilirubin > 2.0 mg/dL
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
- QTc > 450 ms or any clinically significant abnormal finding from an ECG result at screening
- Continuous alcohol intake or inability to stop drinking during the study period
- Continuous smoking or inability to stop smoking throughout the hospitalization during the study period
- Participated in another clinical study or bioequivalence study within 6 months prior to the first administration of the IP
- Donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration of the IP
- Used any prescription drugs or herbal medicines within 14 days, or any over-the-counter (OTC) drugs within 7 days prior to the first administration of the IP
- Used drugs inducing and inhibiting drug-metabolizing enzymes, such as barbitals, within 1 month prior to initiation of the study
- Have been on a diet (especially grapefruit juice or its product) which may affect absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first administration of the IP
- Do not agree to exclude the possibility of pregnancy by using medically acceptable methods of contraception from the first day of administration of the IP up to 7 days after the last day of administration of the IP
- Unwillingness or inability to comply with the diet and lifestyle guidelines required for the study
- Clinically significant abnormal laboratory results or considered ineligible for study participation by the investigator for any other reason
- Women who are pregnant, have a positive serum/urine hCG test, or are breastfeeding
研究组 & 干预措施
sequence 3
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 3: T1 - R - T2
干预措施: BR4002-1 (Drug)
sequence 4
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 4: T1 - T2 - R
干预措施: BR4002-1 (Drug)
sequence 5
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 5: T2 - R - T1
干预措施: BR4002-1 (Drug)
sequence 1
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 1: R - T1 - T2
干预措施: BR4002-1 (Drug)
sequence 2
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 2: R - T2 - T1
干预措施: BR4002-1 (Drug)
sequence 6
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 6: T2 - T1 - R
干预措施: BR4002-1 (Drug)
sequence 6
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 6: T2 - T1 - R
干预措施: BR4002 (Drug)
sequence 5
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 5: T2 - R - T1
干预措施: BR4002 (Drug)
sequence 4
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 4: T1 - T2 - R
干预措施: BR4002 (Drug)
sequence 3
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 3: T1 - R - T2
干预措施: BR4002 (Drug)
sequence 2
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 2: R - T2 - T1
干预措施: BR4002 (Drug)
sequence 1
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
- R(Reference): BR4002-1 (oral intake) 5mg single-dose
- T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator)
- T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator)
sequence 1: R - T1 - T2
干预措施: BR4002 (Drug)
结局指标
主要结局
Pharmacokinetic variables -Area Under the concentration-time Curve from time 0 to t after single dosing(AUCt) of BR4002 and BR4002-1
时间窗: 0~240 hours after medication
PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.
Pharmacokinetic variables - maximum observed plasma concentration(Cmax) of BR4002 and BR4002-1
时间窗: 0~240 hours after medication
PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.
次要结局
- Pharmacokinetic variables - Time of occurrence of Cmax(Tmax) of BR4002 and BR4002-1(0~240 hours after medication)
- Pharmacokinetic variables - Area Under the concentration-time Curve from time 0 to infinite after single dosing(AUCinf) of BR4002 and BR4002-1(0~240 hours after medication)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT04462029
- 其他研究编号
- BR-DPZ-CT-102
日期
- 首次提交
- (6年前)
- 首次发布
- (6年前)
- 主要完成日期
- (5年前)
- 研究完成日期
- (5年前)
- 最近核实
- 最近更新
- (5年前)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 否