A Multi Doses Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects

NCT04857047 | Completed Phase 1

• 1 other identifier: BR-VRNS-CT-101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multiple doses, crossover clinical study to compare the pharmacokinetic characteristics and the safety between administration of BR9003 and BR9003A in healthy adult subjects. Within each period, randomized subjects will be taken 2 dosing regimens of administrating BR9003 once a day for six days or BR9003A twice a day for six days.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• AUC0-24,ss

  Area under the plasma drug concentration-time curve of BR9003 and BR9003A within 24 hours

  0-72 hours after administration

• Cmax,ss

  Maximum concentration of drug in plasma of BR9003 and BR9003A within 24 hours

  0-72 hours after administration

Study Arms (2)

Group A

EXPERIMENTAL

\[Period1\] administration of BR9003A 1mg twice a day for six days \- Wash out for 9days - \[Period2\] administration of BR9003 2mg once a day for six days

Drug: BR9003 2mg; Drug: BR9003A 1mg

Group B

EXPERIMENTAL

\[Period1\] administration of BR9003 2mg once a day for six days \- Wash out for 9days - \[Period2\] administration of BR9003A 1mg twice a day for six days

Drug: BR9003 2mg; Drug: BR9003A 1mg

Interventions

BR9003 2mg DRUG

After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003 tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it.

Group A; Group B

BR9003A 1mg DRUG

After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003A tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it. Another BR9003A tablet will be administered orally with water 150mL around 20:30 after dinner between 18-19:00.

Group A; Group B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 29.0 kg/m2
• Determined to be eligible as subjects through physical examination and interview 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
• Determined to be eligible as subjects as a result of clinical laboratory tests and electrocardiography performed according to this protocol
• Voluntarily decide to participate in the study and provide written consent to follow the study directions after listening

You may not qualify if:

• Those who have clinically significant diseases or a history of the diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric diseases, or urinary system
• Those who have hypersensitivity reactions or a history of clinically significant hypersensitivity reactions to drugs containing varenicline, or drugs containing the same class ingredients, or other drugs
• Those with clinically significant hypotension (systolic blood pressure
• ≤ 90mmHg) or hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg) at the time of screening
• Those with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcer, etc.) or gastrointestinal surgery (however, simple appendectomy or hernia repair are excluded) that may affect the absorption of drugs
• 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
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2
• Those who continue to drink alcohol (\>21 units/week; 1 unit = 10 g = 12.5 mL of pure alcohol), or are unable to abstain from drinking during the clinical study period
• Those who continue to smoke (\>10 cigarettes/day) or cannot stop smoking during hospitalization during the clinical trial period
• Those who have participated in another clinical trial or bioequivalence test (the last day of administration of the investigational product or bioequivalence test drug) within 6 months prior to the first administration date
• Those who have donated whole blood within 60 days prior to the first day of administration or donated blood components (apheresis) within 30 days prior to the first day of administration or who have received a blood transfusion within 30 days
• Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical trial.)
• Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbital, within 30 days prior to the study initiation

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Sang-Heon Cho

  Inha University 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: April 9, 2021
• First Posted: April 23, 2021
• Study Start: March 31, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 28, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)