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

NCT05102903 | Completed Phase 1

• 1 other identifier: BR-SVMC-CT-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetic properties and safety of "BR1016A" and "BR1016B" in healthy adults.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• AUCt of BR1016A and BR1016B

  Area under the plasma drug concentration-time curve of BR1016A and BR1016B

  0-36 hours after administration

• Cmax of BR1016A and BR1016B

  Maximum concentration of drug in plasma of BR1016A and BR1016B

  0-36 hours after administration

Secondary Outcomes (5)

• AUC∞ of BR1016A and BR1016B

  0-36 hours after administration

• AUCt/AUC∞ of BR1016A and BR1016B

  0-36 hours after administration

• Tmax of BR1016A and BR1016B

  0-36 hours after administration

• CL/F of BR1016A and BR1016B

  0-36 hours after administration

• Vz/F of BR1016A and BR1016B

  0-36 hours after administration

Study Arms (2)

A(RT)

OTHER

Reference drug "BR1016B" 1 tablet is administered once in fasted state. After having a break of 7 days or more, study drug "BR1016A" 1 tablet is administered once in fasted state.

Drug: BR1016A; Drug: BR1016B

B(TR)

OTHER

Study drug "BR1016A" 1 tablet is administered once in fasted state. After having a break of 7 days or more, reference drug "BR1016B" 1 tablet is administered once in fasted state.

Drug: BR1016A; Drug: BR1016B

Interventions

BR1016A DRUG

All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.

Also known as: Study drug

A(RT); B(TR)

BR1016B DRUG

All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.

Also known as: Reference drug

A(RT); B(TR)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 19 years or older at screening
• 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
• 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)
• 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
• 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
• 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

You may not qualify if:

• 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)
• 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
• 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
• 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
• 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)
• 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
• 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
• 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)
• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Metro Hospital

Anyang, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Seong Dae Kwon

  Metro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 2, 2021
• Study Start: October 22, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)