A Randomized, Open-label, Multiple Doses, Crossover Clinical Study to Compare the Pharmacokinetic Characteristics and the Safety Between Administration of BR9003 and BR9003A in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- BR9003 2mg
- Conditions
- Smoking Cessation
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Cmax,ss
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Detailed Description
\*Study Objective: After repeated administration of BR9003 2mg and BR9003A 1mg for healthy adult volunteers, the pharmacokinetic properties and safety are evaluated. * Target number of subjects for enrollment (randomization): 24 subjects in total (2 sequence groups(A or B), 12 subjects per sequence group) * Investigational Product 1. Control drug: BR9003A 1mg 2. Test drug: BR9003 2mg * Regimen 1. Control group: Administration of BR9003A 1mg twice a day for six days 2. Test group: Administration of BR9003 2mg once a day for six days
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
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
Arms & Interventions
Group A
\[Period1\] 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
Intervention: BR9003 2mg
Group A
\[Period1\] 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
Intervention: BR9003A 1mg
Group B
\[Period1\] 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
Intervention: BR9003 2mg
Group B
\[Period1\] 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
Intervention: BR9003A 1mg
Outcomes
Primary Outcomes
Cmax,ss
Time Frame: 0-72 hours after administration
Maximum concentration of drug in plasma of BR9003 and BR9003A within 24 hours
AUC0-24,ss
Time Frame: 0-72 hours after administration
Area under the plasma drug concentration-time curve of BR9003 and BR9003A within 24 hours