A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.

NCT04485585 | Completed Phase 1

• 1 other identifier: BR-TMC-CT-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers.

Conditions

Benign Prostatic Hyperplasia (BPH); Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B

  The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).

  0~26 days after medication

• Pharmacokinetic variables - Area under the plasma concentration-time curve from time zero to time t(AUCt) of Part A and B

  The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).

  0~26 days after medication

Secondary Outcomes (2)

• Pharmacokinetic variables - Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) of Part A and B

  0~26 days after medication

• Pharmacokinetic variables - Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) of Part A and B

  0~26 days after medication

Study Arms (1)

Sequence T/M/T+M

EXPERIMENTAL

A total of 36 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(T, M, T+M) assigned to on sequence group in Period 1, Period 2, and Period 3. * Period 1(T): BR9006-1 (Tamsulosin HCL 0.2mg) - 1 capsule QD, five-day repeated-dose * Period 2(M): BR9006-2 (Mirabegron 50mg) - 1 tablet QD, eleven-day repeated-dose * Period 3(T+M): BR9006-1 (Tamsulosin HCL 0.2mg) 1 capsule + BR9006-2 (Mirabegron 50mg) 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: none

Drug: BR9006-1; Drug: BR9006-2

Interventions

BR9006-1 DRUG

* Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose

Also known as: Tamsulosin HCL

Sequence T/M/T+M

BR9006-2 DRUG

* Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose * Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose

Also known as: Mirabegron

Sequence T/M/T+M

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 male adults aged 19 to 55 years at screening.
• The subject's weight is 50kg or more and body mass index (BMI) is 18.0 or more but 30.0 or less.

You may not qualify if:

• Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients (Tamsulosin and Mirabegron) and other ingredients of investigational products, Food Yellow No. 5 (Sunset Yellow FCF) or Sulfonamide.
• 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 (MDRD method used)
• Those with systolic blood pressure \> 150 mmHg or \< 90 mmHg, or diastolic blood pressure \> 95 mmHg or \< 60 mmHg from vital signs at screening.
• Those who took drugs (prescription drugs, OTC, herbal medicine or nutritional supplements (vitamins, etc.)) 2 weeks before screening. (However, those may participate in the trial if their safety and study results are considered to be unaffected according to the investigator's judgment.)
• Those who have a drug abuse problem (especially centrally acting drugs including sleeping pills, centrally acting pain reliever, opiates or psychoactive drugs) or have a history of drug abuse.
• Those who have a history of continuous alcohol intake exceeding 21 units/week (1unit=10g=12.5mL) within 6 months before screening.
• Those who have smoked more than 10 cigarettes a day within 6 months before screening.
• Those who have participated in other clinical trials and have been administered with other investigational drugs 180 days prior to the estimated administration date of this study's investigational drugs (However, is not applicable if the investigational drugs from other trials are not administered).

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13520, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder, Overactive

Interventions

Tamsulosin; mirabegron

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• An-Hye Kim

  CHA University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: July 20, 2020
• Primary Completion: August 16, 2020
• Study Completion: August 26, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

KR (1)