A Randomized, Open-label, Multiple-dose, 6-sequence, 3-treatment, 3-period, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- BR1018-1
- Conditions
- Hypertension
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- AUC0-24,ss
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and compare the safety and tolerability after repeated separate or combined administrations of BR1018-1 and BR1018-2 in healthy adults.
Detailed Description
A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence group. The Investigational Products wil be according to the treatment group (A,B,C) assigned to each sequence group in Period 1, Period 2 and Period 3.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults aged 19 to 55 years at screening
- •Those who weigh at least 50 kg at the time of screening and have a calculated body mass index (BMI) within the range of 18.0 to 30.0 kg/m2
- •Those who have been determined to be eligible as subjects through physical examinations and interviews conducted in accordance with this protocol. In other words, those who have no congenital or chronic diseases and have no abnormal symptoms or findings based on medical examination results within the last 3 years
- •Those who have been determined to be eligible as subjects as a result of clinical laboratory tests and electrocardiography performed according to this protocol (if the results are within the reference values of Inha University Hospital or if the investigator determines that the clinical laboratory test and electrocardiography results are not clinically significant even if they are out of range)
- •Those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study
Exclusion Criteria
- •Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof.
- •Those who have hypersensitivity reactions to drugs containing fimasartan, amlodipine, ezetimibe, atorvastatin, or same-class ingredients, yellow no. 5 (sunset yellow FCF), dihydropyridine derivatives, or to other drugs (aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivity reactions thereto.
- •Those who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- •Those who have a history of gastrointestinal diseases (e.g., Crohn's disease, ulcerative disease, etc.) or gastrointestinal surgery (however, simple appendectomy or hernia repair are excluded) that may affect the absorption of drugs
- •Those who have clinically significant hypotension (systolic blood pressure ≤ 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
- •Those who show any of the following results in the screening tests
- •AST or ALT \> 2 times the upper limit of the normal range
- •Total bilirubin \> 2.0 mg/dL
- •CK \> 2 times the upper limit of the normal range
- •Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
Arms & Interventions
Sequence 1
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 1: A-B-C
Intervention: BR1018-1
Sequence 1
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 1: A-B-C
Intervention: BR1018-2
Sequence 2
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 2: A-C-B
Intervention: BR1018-1
Sequence 2
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 2: A-C-B
Intervention: BR1018-2
Sequence 3
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 3: B-A-C
Intervention: BR1018-1
Sequence 3
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 3: B-A-C
Intervention: BR1018-2
Sequence 4
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 4: B-C-A
Intervention: BR1018-1
Sequence 4
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 4: B-C-A
Intervention: BR1018-2
Sequence 5
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 5: C-A-B
Intervention: BR1018-1
Sequence 5
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 5: C-A-B
Intervention: BR1018-2
Sequence 6
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 6: C-B-A
Intervention: BR1018-1
Sequence 6
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 6: C-B-A
Intervention: BR1018-2
Outcomes
Primary Outcomes
AUC0-24,ss
Time Frame: 0-48 hours after administration
Area under the plasma drug concentration-time curve from 0 to time t of BR1018-1 and BR1018-2
Cmax,ss
Time Frame: 0-48 hours after administration
Maximum concentration of drug in plasma of BR1018-1 and BR1018-2