An Open-label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- BR1015-1
- Conditions
- Hypertension
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- [Part A] Cmax,ss of BR1015-1
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
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)
Arms & Interventions
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
A total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3. * Period 1(BR1015-1): BR1015-1(Fimasartan 60mg) - 1 tablet QD, five-day repeated-dose * Period 2(BR1015-2): BR1015-2(Indapamide 1.5mg) - 1 tablet QD, five-day repeated-dose * Period 3(BR1015-1 + BR1015-2): BR1015-1 (Fimasartan 60mg) 1 tablet + BR1015-2 (Indapamide 1.5mg) 1 tablet QD, five-day repeated-dose * Washout period between Period 1 and Period 2: five days * Washout period between Period 2 and Period 3: two days
Intervention: BR1015-1
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
A total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3. * Period 1(BR1015-1): BR1015-1(Fimasartan 60mg) - 1 tablet QD, five-day repeated-dose * Period 2(BR1015-2): BR1015-2(Indapamide 1.5mg) - 1 tablet QD, five-day repeated-dose * Period 3(BR1015-1 + BR1015-2): BR1015-1 (Fimasartan 60mg) 1 tablet + BR1015-2 (Indapamide 1.5mg) 1 tablet QD, five-day repeated-dose * Washout period between Period 1 and Period 2: five days * Washout period between Period 2 and Period 3: two days
Intervention: BR1015-2
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
A total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3. * Period 1(BR1015-1): BR1015-1(Fimasartan 60mg) - 1 tablet QD, five-day repeated-dose * Period 2(BR1015-2): BR1015-2(Indapamide 1.5mg) - 1 tablet QD, five-day repeated-dose * Period 3(BR1015-1 + BR1015-2): BR1015-1 (Fimasartan 60mg) 1 tablet + BR1015-2 (Indapamide 1.5mg) 1 tablet QD, five-day repeated-dose * Washout period between Period 1 and Period 2: five days * Washout period between Period 2 and Period 3: two days
Intervention: BR1015-1 + BR1015-2
Outcomes
Primary Outcomes
[Part A] Cmax,ss of BR1015-1
Time Frame: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-1 at steady state (Cmax,ss).
[Part B] Cmax,ss of BR1015-2
Time Frame: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-2 at steady state (Cmax,ss).
[Part A] AUCtau of BR1015-1
Time Frame: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-1 at steady state. (AUCtau,ss)
[Part B] AUCtau of BR1015-2
Time Frame: 0~24 hour after administration at Day 5.
Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-2 at steady state. (AUCtau,ss)
Secondary Outcomes
- [Part A] AUClast of BR1015-1(0~48 hour after administration)
- [Part B] AUClast of BR1015-2(0~48 hour after administration)
- [Part A] AUCinf of BR1015-1(0~48 hour after administration)
- [Part B] AUCinf of BR1015-2(0~48 hour after administration)
- [Part B] Tmax of BR1015-2(0~24 hour after administration)
- [Part A] Tmax of BR1015-1(0~24 hour after administration)
- [Part A] t1/2 of BR1015-1(0~48 hour after administration)
- [Part B] t1/2 of BR1015-2(0~48 hour after administration)