Hepatocellular CarcinomaPhase 1NCT05068193
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
A Phase 1 study testing BR2008-1 (R) and BR2008 (T) in people with Hepatocellular Carcinoma, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- BR2008-1 (R) and BR2008 (T)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2021to 6 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
<Inclusion Criteria>
- Healthy adults aged over 19 years at screening
- Those who have no congenital or chronic diseases and have no abnormal symptoms or findings based on medical examination results
- Determined to be eligible subjects as a result of clinical laboratory tests and electrocardiography performed according to this protocol at screening
- Those who have calculated body mass index(BMI) within the range of 18.0 to 30.0 kg/m2
- Those who do not have a history of the psychiatric diseases within the last 5 years before screening
- Those who do not have a history of gastrointestinal diseases (e.g., Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (however, simple appendectomy or hernia repair are excluded) that may affect the absorption of drugs
- 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 took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbital, within 30 days prior to the first administration date, or took any drugs that may the clinical trial
- Those who continue to drink alcohol (Male: >5 units/week, Female: >2.5 units/week) within 1 month prior to the first administration date
- Those who continue to smoke (>10 cigarettes/day) or cannot stop smoking during hospitalization throughout the entire period from the date of 48 hours before the first administration of the investigational product to the last pharmacokinetic blood sampling
- Those who have been determined by the investigator to be ineligible to participate in the clinical trial
- 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 2 months, or donated blood components (apheresis) within 2 weeks, or who have received a blood transfusion within 30 days prior to screening
- 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 8 weeks after the last administration of the investigational product
- Those with severe hepatic impairment, or any of the following results in the screening tests
- Total bilirubin ≥ 1.5 x ULN
- AST(SGOT) or ALT(SGPT) ≥ 2 x ULN
- r-GTP ≥ 1.5 x ULN
- Those with severe renal impairment, or serum creatinine levels upper than 1.5 times of ULN
- Those with a predisposition to bleeding, or taking anticoagulants(Warfarin, phenprocoumon), or taking concomitant medications that increase the risk of bleeding
- Those with cardiovascular disease (heart ischemia and infarction)
- Those with systolic blood pressure<90mmHg or >140mmHg, or diastolic blood pressure <60mmHg or >90mmHg
- Those who have hypersensitivity reactions to "BR2008" or "BR2008-1"
- Pregnant woman, potentially pregnant woman, or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers
- Conditions
- Hepatocellular Carcinoma
- Being tested
- BR2008-1 (R), BR2008 (T)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR2008-1 (R)Drug
After fasting at least 10 hours, two tablets of BR2008-1 will be administered orally with 150mL of water around 8 a.m.
BR2008 (T)Drug
After fasting at least 10 hours, one tablet of BR2008 will be administered orally with 150mL of water around 8 a.m.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II.
*Sequence 1
[Period I] Administration of BR2008-1 (single dose)
- Wash out for 2 weeks
[Period II] Administration of BR2008 (single dose) Receives: Drug: BR2008-1 (R); Drug: BR2008 (T) |
| Sequence 2 | Other | The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II.
*Sequence 2
[Period I] Administration of BR2008 (single dose)
* Wash out for 2 weeks
[Period II] Administration of BR2008-1 (single dose) Receives: Drug: BR2008-1 (R); Drug: BR2008 (T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Area under the plasma drug concentration-time curve from time 0 to time t of BR2008 and BR2008-1
Measured: 0-120 hours after administration
Cmax
Maximum concentration of drug in plasma of BR2008 and BR2008-1
Measured: 0-120 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 posted5 Oct 2021
- Study start6 Sep 2021
- Primary completion28 Nov 2021
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068193
- Sponsor's protocol ID
- BR-RGR-CT-101
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05068193
- Acronym / sponsor ID
- BR-RGR-CT-101
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 5 Oct 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.
A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: BR2008-1 (R), Drug: BR2008 (T)The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II. *Sequence 1 [Period I] Administration of BR2008-1 (single dose) - Wash out for 2 weeks [Period II] Administration of BR2008 (single dose) |
| Sequence 2 | Other | Drug: BR2008-1 (R), Drug: BR2008 (T)The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II. *Sequence 2 [Period I] Administration of BR2008 (single dose) * Wash out for 2 weeks [Period II] Administration of BR2008-1 (single dose) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BR2008-1 (R)After fasting at least 10 hours, two tablets of BR2008-1 will be administered orally with 150mL of water around 8 a.m. | Drug | Sequence 1, Sequence 2 |
| BR2008 (T)After fasting at least 10 hours, one tablet of BR2008 will be administered orally with 150mL of water around 8 a.m. | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCt
Time frame: 0-120 hours after administration
Area under the plasma drug concentration-time curve from time 0 to time t of BR2008 and BR2008-1
Cmax
Time frame: 0-120 hours after administration
Maximum concentration of drug in plasma of BR2008 and BR2008-1
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 20 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BR2008-1 (R) and BR2008 (T) in people with Hepatocellular Carcinoma, 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?
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 20 Apr 2022. 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?
AUCt (time frame: 0-120 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 20 Apr 2022.