A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers

• Status: Enrolling by invitation
• Trial end date: 2021-10-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Indapamide

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.