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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05068193
• Other study ID #: BR-RGR-CT-101
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2021
• Est. completion date: January 6, 2022

Study information

• Verified date: September 2021
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 6, 2022
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

<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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Bestian Hospital	Osong

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	Area under the plasma drug concentration-time curve from time 0 to time t of BR2008 and BR2008-1	0-120 hours after administration
Primary	Cmax	Maximum concentration of drug in plasma of BR2008 and BR2008-1	0-120 hours after administration