Trials Sponsors Conditions Drugs Pricing

Conditions

Hyperlipidemia (E.G., Hypercholesterolemia)Hypertension

Outcome Measures

Primary Outcomes (2)

AUC0-24,ss
Area under the plasma drug concentration-time curve from 0 to time t of BR1018-1 and BR1018-2
0-48 hours after administration
Cmax,ss
Maximum concentration of drug in plasma of BR1018-1 and BR1018-2
0-48 hours after administration

Study Arms (6)

Sequence 1

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 1: A-B-C

Drug: BR1018-1Drug: BR1018-2

Sequence 2

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 2: A-C-B

Drug: BR1018-1Drug: BR1018-2

Sequence 3

EXPERIMENTAL

Interventions

BR1018-1Drug

Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days. Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

BR1018-2

Eligibility Criteria

Age19 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy adults aged 19 to 55 years at screening
Those who weigh at least 50 kg at the time of screening and have a calculated body mass index (BMI) within the range of 18.0 to 30.0 kg/m2

Sponsors & Collaborators

Boryung Pharmaceutical Co., Ltd
Industrylead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

MeSH Terms

Conditions

HypertensionHyperlipidemiasHypercholesterolemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Enrollment

36 participants (actual enrollment reported by the registry).

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

July 13, 2022

First Posted

July 15, 2022

Study Start

August 4, 2022

Actual (reported)

Primary Completion

You may not qualify if:

Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof.
Those who have hypersensitivity reactions to drugs containing fimasartan, amlodipine, ezetimibe, atorvastatin, or same-class ingredients, yellow no. 5 (sunset yellow FCF), dihydropyridine derivatives, or to other drugs (aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivity reactions thereto.
Those who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
Those who have a history of gastrointestinal diseases (e.g., Crohn's disease, ulcerative disease, etc.) or gastrointestinal surgery (however, simple appendectomy or hernia repair are excluded) that may affect the absorption of drugs
Those who have clinically significant hypotension (systolic blood pressure ≤ 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
Those who show any of the following results in the screening tests
AST or ALT \> 2 times the upper limit of the normal range
Total bilirubin \> 2.0 mg/dL
CK \> 2 times the upper limit of the normal range
Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
Those who continue to drink alcohol (\>21 units/week; 1 unit = 10 g = 12.5 mL of pure alcohol), or who are unable to abstain from drinking during the clinical study period
Those who continue to smoke (\>10 cigarettes/day), or who are unable stop smoking during hospitalization within the clinical study period
Those who have participated in another clinical study 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 60 days prior to the first day of administration or donated blood components within 30 days prior to the first day of administration or who have received a blood transfusion within 30 days
Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.)
+7 more criteria

A Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 in Healthy Adult Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (6)

Sequence 1

Sequence 2

Sequence 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Sequence 4

Sequence 5

Sequence 6

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (6)

Sequence 1

Sequence 2

Sequence 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Sequence 4

Sequence 5

Sequence 6

You may not qualify if:

Data Sharing

Source record

Locations