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

NCT05068193 | Completed Phase 1

• 1 other identifier: BR-RGR-CT-101
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• Cmax

  Maximum concentration of drug in plasma of BR2008 and BR2008-1

  0-120 hours after administration

Study Arms (2)

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)

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)

Drug: BR2008-1 (R); Drug: BR2008 (T)

Interventions

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.

Sequence 1; Sequence 2

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.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Bestian Hospital

Osŏng, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 5, 2021
• Study Start: September 6, 2021
• Primary Completion: November 28, 2021
• Study Completion: January 6, 2022
• Last Updated: April 20, 2022

Record last verified: 2021-09

Locations

KR (1)