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

NCT04846998 | Completed Phase 1

• 1 other identifier: BR-VRNS-CT-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9003 compared with BR9003A in healthy adult subjects

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• AUCt

  Area under the plasma drug concentration-time curve from 0 to time t of BR9003 and BR9003A

  0-72 hours after administration

• Cmax

  Maximum concentration of drug in plasma of BR9003 and BR9003A

  0-72 hours after administration

Study Arms (6)

Sequence 1

EXPERIMENTAL

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

Drug: BR9003; Drug: BR9003A

Sequence 2

EXPERIMENTAL

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

Drug: BR9003; Drug: BR9003A

Sequence 3

EXPERIMENTAL

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

Drug: BR9003; Drug: BR9003A

Sequence 4

EXPERIMENTAL

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

Drug: BR9003; Drug: BR9003A

Sequence 5

EXPERIMENTAL

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

Drug: BR9003; Drug: BR9003A

Sequence 6

EXPERIMENTAL

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

Drug: BR9003; Drug: BR9003A

Interventions

BR9003 DRUG

Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

BR9003A DRUG

Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

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 to and fully understanding the detailed explanation on this study

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
• Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration

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 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 14, 2021
• First Posted: April 15, 2021
• Study Start: March 25, 2021
• Primary Completion: May 4, 2021
• Study Completion: May 18, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)