A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and Safety of "BR1016C" With "BR1016D" in Healthy Volunteers

BR-SVMC-CT-102

To evaluate the pharmacokinetic properties and safety of "BR1016C" and "BR1016D" in healthy adults.

2021-10-27

2021-12-18

2021-12-18

Completed

Early phase I

60

Inclusion Criteria: 1. Individuals aged 19 years or older at screening 2. Individuals with an index BMI of 18.0 to 30.0 for obesity (BMI calculation: weight (kg)/height (m)2) * Males weighing 50 kg or more * Females weighing 45 kg or more 3. Those who do not have clinically significant congenital or chronic diseases and do not have pathological symptoms or findings as a result of medical examination (electroencephalography, electrocardiogram, chest and stomach endoscopy or gastrointestinal radiography, if necessary) 4. A person who has been determined by the principal investigator (or a delegated sub-investigator) to be eligible as a subject based on the results of electrocardiography (ECG) and clinical laboratory tests such as hematology, blood chemistry, serology, urinalysis, etc. conducted according to the properties of the drug 5. Those who voluntarily decided to participate in the study after being given a detailed explanation of this clinical trial and understanding it fully, and provided a written consent to follow the precautions during the clinical study period 6. Those who agreed to rule out the possibility of a pregnancy by using a medically accepted method of contraception\* for themselves, their spouse, or their partner from the date of screening until 7 days after the date of the last investigational product administration and agreed not to provide sperm or eggs \*Medically acceptable methods of contraception: Combined use of intrauterine device (IUD, IUS), vasectomy, tubal ligation and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used Exclusion Criteria: 1. Those who have taken drugs that induce and inhibit drug metabolizing enzymes such as barbitals within 30 days prior to the initiation of the study (date of first administration) or who have taken drugs that may interfere with this study within 10 days prior to the initiation of the study (date of first administration) 2. Those who have participated in a bioequivalence study or other clinical study within 180 days prior to the initiation of the study (date of first administration) and have received the investigational product 3. Those who have donated whole blood or blood within 60 days prior to the first day of administration, or donated blood components within 14 days prior to the first day of administration or who have received a blood transfusion within 30 days 4. Those who have gastrointestinal disease or history of gastrointestinal resection (except for hernia surgery or simple appendectomy) that may affect the absorption of the drug 5. Those who have continued drinking alcohol within 30 days prior to the initiation of the study (date of first administration) * Male: 4 drinks/time, more than 14 drinks/week * Female: 3 drinks/time, more than 7 drinks/week (1 drink: 45 mL of spirits, 150 mL of wine, 350-360 mL of beer, 300 mL of makgeolli, 90 mL of 20% soju) 6. Smokers who smoked more than 10 cigarettes a day within the 90 days prior to the initiation of the study (date of first administration) and who are unable to stop smoking from 48 hours prior to the first administration of the investigational product until the last blood collection 7. Those who have ingested or cannot refrain from ingesting caffeine-containing foods (e.g., coffee, green tea, tea, soda, coffee milk, sour tonic drinks, etc.) from 48 hours prior to the initiation of the study (date of first administration) until the last blood collection 8. Those who have had an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug (e.g., consumption of grapefruit juice (at least 1L per day) within 7 days prior to administration of the investigational product) 9. Those who meet any of the criteria below in the clinical laboratory test results at screening * AST (SGOT) or ALT (SGPT) or γ-GTP levels in blood greater than 1.5 times the upper limit of the normal range (ULN) * eGFR \< 60mL/min/1.73 m2 * Sodium(Na) \< 135 mEq/l * Potassium(K) \> 5.0 mEq/l * Positive results in HBsAg, HCV-Ab, HIV antibody, and VDRL (Syphilis/qualitative) test 10. Those who meet any of the criteria below in the results of vital sign measurement at screening * Systolic blood pressure: Less than 90 mmHg or more than 139 mmHg * Diastolic blood pressure: Less than 60 mmHg or more than 90 mmHg * Pulse rate: Greater than 100/min 11. Patients with the following conditions * Those who have a hypersensitivity reaction to the active ingredient of this drug or to any component of this drug * Those who are receiving an angiotensin-converting enzyme (ACE) inhibitor or have not passed 36 hours after discontinuing the administration * Those who have a history of angioedema when angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor antagonist (ARB) was administered * Those with hereditary or idiopathic angioedema * Severe hepatic impairment, cirrhosis or biliary obstruction, cholestasis * Those who are receiving a combination administration with aliskiren for diabetes or moderate to severe renal impairment (eGFR \< 60mL/min/1.73 m2) * Those with primary hyperaldosteronism 12. Those with a history of clinically significant psychiatric illness within 5 years prior to the screening visit 13. For female volunteers, pregnant women or those who may be pregnant or are breastfeeding 14. Individuals who the principal investigator (or a delegated sub-investigator) has determined to be ineligible for this clinical study for reasons other than the inclusion/exclusion criteria described above

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-05-24