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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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>

  1. Healthy adults aged over 19 years at screening
  2. Those who have no congenital or chronic diseases and have no abnormal symptoms or findings based on medical examination results
  3. Determined to be eligible subjects as a result of clinical laboratory tests and electrocardiography performed according to this protocol at screening
  4. Those who have calculated body mass index(BMI) within the range of 18.0 to 30.0 kg/m2
  5. Those who do not have a history of the psychiatric diseases within the last 5 years before screening
  6. 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
  7. 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>

  1. 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
  2. Those who continue to drink alcohol (Male: >5 units/week, Female: >2.5 units/week) within 1 month prior to the first administration date
  3. 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
  4. Those who have been determined by the investigator to be ineligible to participate in the clinical trial
  5. 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
  6. 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
  7. 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
  8. 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
  1. Those with severe renal impairment, or serum creatinine levels upper than 1.5 times of ULN
  2. Those with a predisposition to bleeding, or taking anticoagulants(Warfarin, phenprocoumon), or taking concomitant medications that increase the risk of bleeding
  3. Those with cardiovascular disease (heart ischemia and infarction)
  4. Those with systolic blood pressure<90mmHg or >140mmHg, or diastolic blood pressure <60mmHg or >90mmHg
  5. Those who have hypersensitivity reactions to "BR2008" or "BR2008-1"
  6. Pregnant woman, potentially pregnant woman, or breast-feeding woman

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Bestian Hospital

    Osŏng

Other trials in South Korea

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

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 groups in NCT05068193
Study groupRoleWhat they receive
Sequence 1OtherThe 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 2OtherThe 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.

  1. 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

  2. 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.

  1. First posted5 Oct 2021
  2. Study start6 Sep 2021
  3. Primary completion28 Nov 2021
  4. Study completion6 Jan 2022

Resources

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)
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

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.

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