Smoking CessationPhase 1NCT04857047
A Multi Doses Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects
A Phase 1 study testing BR9003 2mg and BR9003A 1mg in people with Smoking Cessation, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- BR9003 2mg and BR9003A 1mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Mar 2021to 28 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Pregnant woman, potentially pregnant woman, or breast-feeding woman
- Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy using a medically acceptable methods of contraception* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical trial
- Those who are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical trial
- Those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical trial due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Control drug: BR9003A 1mg
- Test drug: BR9003 2mg
- Regimen
- Control group: Administration of BR9003A 1mg twice a day for six days
- Test group: Administration of BR9003 2mg once a day for six days
- Conditions
- Smoking Cessation
- Being tested
- BR9003 2mg, BR9003A 1mg
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR9003 2mgDrug
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.
BR9003A 1mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: BR9003 2mg; Drug: BR9003A 1mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24,ss
Area under the plasma drug concentration-time curve of BR9003 and BR9003A within 24 hours
Measured: 0-72 hours after administration
Cmax,ss
Maximum concentration of drug in plasma of BR9003 and BR9003A within 24 hours
Measured: 0-72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start31 Mar 2021
- Primary completion15 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang-Heon Cho, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857047
- Sponsor's protocol ID
- BR-VRNS-CT-101
- Status last verified
- Aug 2021
- First submitted
- 9 Apr 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04857047
- Acronym / sponsor ID
- BR-VRNS-CT-101
- Conditions
- Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Control drug: BR9003A 1mg
- Test drug: BR9003 2mg
- Regimen
- Control group: Administration of BR9003A 1mg twice a day for six days
- Test group: Administration of BR9003 2mg once a day for six days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: BR9003 2mg, Drug: BR9003A 1mg[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 |
| Group B | Experimental | Drug: BR9003 2mg, Drug: BR9003A 1mg[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 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR9003 2mgAfter 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. | Drug | Group A, Group B |
| BR9003A 1mgAfter 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. | Drug | Group A, Group B |
Primary outcome
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
Cmax,ss
Time frame: 0-72 hours after administration
Maximum concentration of drug in plasma of BR9003 and BR9003A within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Heon Cho principal investigator
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BR9003 2mg and BR9003A 1mg in people with Smoking Cessation, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-24,ss (time frame: 0-72 hours after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.