Clinical trial NCT05097794: A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers
Official title: An Open-label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-sequence, 3-period study.
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate pharmacokinetic interactions (Drug-Drug interaction) and safety between "BR1015-1" and "BR1015-2" in healthy volunteers.

Detailed description: \*Study Objective: After repeated administration of BR1015-1 and BR1015-2 for healthy volunteers, the pharmacokinetic interactions and safety are evaluated.

\*Investigational Product (and regimen)

1. BR1015-1: Administration of BR1015-1 60 mg once a day for 5 days
2. BR1015-2: Administration of BR1015-2 1.5 mg once a day for 5 days
3. BR1015-1+BR1015-2: Co-administration of BR1015-1 60 mg and BR1015-2 1.5 mg once a day for 5 days

Eligibility criteria: Inclusion Criteria:

* Subjects are given sufficient explanations about the trial objectives and contents as well as properties of investigational drugs before participating in the trial, and will voluntarily express their consent by signing an IRB-approved written consent to participate in the trial.
* Healthy adults aged 19 to 55 years at screening.
* The subject's weight is 50 kg or more for males, 45 kg or more for females, and body mass index (BMI) is 18.0 or more but 30.0 kg/m2 or less.

Exclusion Criteria:

* Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients and other ingredients of investigational products.
* Those who have history of clinically significant diseases including allergy reaction to Yellow No. 5 (Sunset Yellow FCF).
* Those who have a history of clinically significant diseases related to liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, cardiovascular system (including orthostatic hypotension), etc.
* Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) and operations that may influence the absorption of investigational drugs. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
* Those with abnormal findings from the screening tests (medical interview, vital signs, electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to have clinical significance.
* Those who are positive to HBsAg, HCV Ab, HIV Ab, VDRL tests at screening.
* Those with any of the following results at screening:
* AST or ALT \> twice the upper limit of normal range
* T. bilirubin \> twice the upper limit of normal range
* Estimated glomerular filtration rate (e-GFR) \< 60 mL/min/1.73m2 (CKD-EPI method used)
* Na \> 150 mEq/L or \<130 mEq/L
* K \> 5.5 mEq/L or \<3.0 mEq/L
* Those with systolic blood pressure \> 160 mmHg or \< 110 mmHg, or diastolic blood pressure \> 100 mmHg or \< 70 mmHg from vital signs at screening.
* Others who are judged to be ineligible to participate in the trial by the investigator.

Primary outcomes:
measure: [Part A] Cmax,ss of BR1015-1
timeFrame: 0~24 hour after administration at Day 5.
measure: [Part B] Cmax,ss of BR1015-2
timeFrame: 0~24 hour after administration at Day 5.
measure: [Part A] AUCtau of BR1015-1
timeFrame: 0~24 hour after administration at Day 5.
measure: [Part B] AUCtau of BR1015-2
timeFrame: 0~24 hour after administration at Day 5.
Secondary outcomes:
measure: [Part A] AUClast of BR1015-1
timeFrame: 0~48 hour after administration
measure: [Part B] AUClast of BR1015-2
timeFrame: 0~48 hour after administration
measure: [Part A] AUCinf of BR1015-1
timeFrame: 0~48 hour after administration
measure: [Part B] AUCinf of BR1015-2
timeFrame: 0~48 hour after administration
measure: [Part A] Tmax of BR1015-1
timeFrame: 0~24 hour after administration
measure: [Part B] Tmax of BR1015-2
timeFrame: 0~24 hour after administration
measure: [Part A] t1/2 of BR1015-1
timeFrame: 0~48 hour after administration
measure: [Part B] t1/2 of BR1015-2
timeFrame: 0~48 hour after administration
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Seongnam-si
Study officials:
affiliation: CHA University
name: An-Hye Kim, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: