A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers

April 19, 2022 updated by: Boryung Pharmaceutical Co., Ltd

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

<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
  9. Those with severe renal impairment, or serum creatinine levels upper than 1.5 times of ULN
  10. Those with a predisposition to bleeding, or taking anticoagulants(Warfarin, phenprocoumon), or taking concomitant medications that increase the risk of bleeding
  11. Those with cardiovascular disease (heart ischemia and infarction)
  12. Those with systolic blood pressure<90mmHg or >140mmHg, or diastolic blood pressure <60mmHg or >90mmHg
  13. Those who have hypersensitivity reactions to "BR2008" or "BR2008-1"
  14. Pregnant woman, potentially pregnant woman, or breast-feeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence 1

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)
Drug: 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: BR2008 (T)
After fasting at least 10 hours, one tablet of BR2008 will be administered orally with 150mL of water around 8 a.m.
Other: Sequence 2

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)
Drug: 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: BR2008 (T)
After fasting at least 10 hours, one tablet of BR2008 will be administered orally with 150mL of water around 8 a.m.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-120 hours after administration
Cmax
Time Frame: 0-120 hours after administration
Maximum concentration of drug in plasma of BR2008 and BR2008-1
0-120 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2021

Primary Completion (Actual)

November 28, 2021

Study Completion (Actual)

January 6, 2022

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-RGR-CT-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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