Overview

A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016A" With "BR1016B" in Healthy Volunteers

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the pharmacokinetic properties and safety of "BR1016A" and "BR1016B" in healthy adults.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Criteria
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

- Blood AST (GOT) or ALT (GPT) or GGT (γGT) levels greater than 1.5 times the upper
limit of the normal range (ULN)

- eGFR < 60mL/min/1.73 m2

- Na < 135 mmol/L

- K > 5.5 mmol/L

- Positive results for HBs Ag, HCV Ab, HIV Ab, VDRL (RPR)

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