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A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fasting Conditions in Healthy Volunteers

Primary Purpose

Hypertension

Status
Active
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BR1015
BR1015-1
BR1015-2
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit. Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc. Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial* from the date of the first administration of the investigational products to 14 days after the last administration and disagrees to provide their sperm or ovum. Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. Exclusion Criteria: Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs) Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products) Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery) In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

Sites / Locations

  • Clinical Research Center, H PLUS Yangji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BR1015

BR1015-1 + BR1015-2

Arm Description

Outcomes

Primary Outcome Measures

AUCτ
Area under the concentration-time curve from time zero to time τ
Cmax
Maximum concentration of drug in plasma

Secondary Outcome Measures

Full Information

First Posted
August 16, 2023
Last Updated
August 22, 2023
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06008028
Brief Title
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fasting Conditions in Healthy Volunteers
Official Title
An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1015" and co-administration of "BR1015-1" and "BR1015-2" under fasting conditions in healthy volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BR1015
Arm Type
Experimental
Arm Title
BR1015-1 + BR1015-2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BR1015
Intervention Description
One tablet administered alone
Intervention Type
Drug
Intervention Name(s)
BR1015-1
Intervention Description
One tablet administered alone
Intervention Type
Drug
Intervention Name(s)
BR1015-2
Intervention Description
One tablet administered alone
Primary Outcome Measure Information:
Title
AUCτ
Description
Area under the concentration-time curve from time zero to time τ
Time Frame
0-72 hours after administration
Title
Cmax
Description
Maximum concentration of drug in plasma
Time Frame
0-72 hours after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit. Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc. Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial* from the date of the first administration of the investigational products to 14 days after the last administration and disagrees to provide their sperm or ovum. Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. Exclusion Criteria: Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs) Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products) Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery) In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Facility Information:
Facility Name
Clinical Research Center, H PLUS Yangji Hospital
City
Seoul
State/Province
Gwanakgu
ZIP/Postal Code
08779
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fasting Conditions in Healthy Volunteers

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