A Randomized, Open-label, Three-treatment, Six-sequence, Three-period, Crossover Clinical Study to Compare the Pharmacokinetic Characteristics Between Twice Daily Administration of BR9003A and Once Daily Administration of BR9003 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- BR9003
- Conditions
- Smoking Cessation
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUCt
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Detailed Description
A total of 24 subjects will be randomized into 6 sequence groups. The Investigational Products wil be according to the treatment group (A,B,C) assigned to each sequence group in Period 1, Period 2 and Period 3.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Sequence 1
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
Intervention: BR9003
Sequence 1
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
Intervention: BR9003A
Sequence 2
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
Intervention: BR9003
Sequence 2
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
Intervention: BR9003A
Sequence 3
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
Intervention: BR9003
Sequence 3
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
Intervention: BR9003A
Sequence 4
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
Intervention: BR9003
Sequence 4
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
Intervention: BR9003A
Sequence 5
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
Intervention: BR9003
Sequence 5
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
Intervention: BR9003A
Sequence 6
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
Intervention: BR9003
Sequence 6
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
Intervention: BR9003A
Outcomes
Primary Outcomes
AUCt
Time Frame: 0-72 hours after administration
Area under the plasma drug concentration-time curve from 0 to time t of BR9003 and BR9003A
Cmax
Time Frame: 0-72 hours after administration
Maximum concentration of drug in plasma of BR9003 and BR9003A