A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability of BR4002 Comparing to BR4002-1 in Healthy Volunteers
概览
- 阶段
- 早期 1 期
- 干预措施
- BR4002-1
- 疾病 / 适应症
- Dementia Alzheimers
- 发起方
- Boryung Pharmaceutical Co., Ltd
- 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
- 状态
- 已完成
- 最后更新
- 5年前
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.
研究者
入排标准
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
研究组 & 干预措施
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
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
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
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
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
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
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
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
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
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
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
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
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)