Study to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.

NCT07322991 | Completed Phase 1

• 1 other identifier: IY-DDI2025
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males.

Conditions

Healthy Adult Male

Keywords

Urology; Drug-Drug Interaction

Outcome Measures

Primary Outcomes (4)

• Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss)

  The total drug exposure of finasteride over the dosing interval at steady state.

  Measured at steady state after repeated dosing.(Day 8 compared to Day 3)

• Finasteride Maximum Plasma Concentration at steady state (Cmax,ss)

  The peak plasma concentration of finasteride observed at steady state.

  Measured at steady state after repeated dosing.(Day 8 compared to Day 3)

• Tamsulosin Area Under the Curve during the dosing interval at steady state (AUCτ,ss)

  The total drug exposure of tamsulosin over the dosing interval at steady state.

  Measured at steady state after repeated dosing.(Day 8 compared to Day 5)

• Tamsulosin Maximum Plasma Concentration at steady state (Cmax,ss)

  The peak plasma concentration of tamsulosin observed at steady state.

  Measured at steady state after repeated dosing.(Day 8 compared to Day 5)

Secondary Outcomes (14)

• Finasteride Time to Maximum Plasma Concentration at steady state (Tmax,ss)

  Days 3 and 8

• Finasteride Elimination Half-Life at Steady State (t1/2,ss)

  Days 3 and 8

• Finasteride Apparent Clearance at Steady State (CLss/F)

  Days 3 and 8

• Finasteride Minimum Plasma Concentration at Steady State (Cmin,ss)

  Days 1, 2, 7, and 8

• Finasteride Average Plasma Concentration at Steady State (Cav,ss)

  Days 3 and 8

Study Arms (2)

Part A

EXPERIMENTAL

IY001 -\> IY001 + IY002

Drug: IY001(Finasteride); Drug: IY002(Tamsulosin)

Part B

EXPERIMENTAL

IY002 -\> IY001 + IY002

Drug: IY001(Finasteride); Drug: IY002(Tamsulosin)

Interventions

IY002(Tamsulosin) DRUG

Subjects will receive IY002 once daily for 5 days, followed by co-administration of IY001 and IY002 once daily for 3 days.

Part A; Part B

IY001(Finasteride) DRUG

Subjects will receive IY001 once daily for 3 days, followed by co-administration of IY001 and IY002 once daily for 5 days.

Part A; Part B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: This study enrolls only male participants because the Investigational Product contain ingredients contraindicated for use in females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males aged between 19 and 55 years at screening.
• Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m² (BMI calculated as weight \[kg\] / height \[m\]²).
• No clinically significant congenital or chronic diseases, and no pathological signs or symptoms based on internal medicine examination (including EEG, ECG, chest or upper gastrointestinal endoscopy, or gastrointestinal radiographic examination, if necessary).
• Considered suitable for participation by the principal investigator (or delegated sub-investigator) based on diagnostic tests such as hematology, blood chemistry, serology, urinalysis, ECG, suicide risk assessment, and depression scale evaluation conducted in accordance with the characteristics of the investigational drugs.
• Able to provide written informed consent after receiving a detailed explanation of the clinical trial and voluntarily agreeing to participate and comply with study requirements during the trial period.
• Agree to use highly effective contraception\* (excluding hormonal methods) and refrain from donating sperm from the first dose until at least 4 weeks after the last dose of the investigational drugs. This includes agreement that the subject or their partner will avoid pregnancy.
• \*Highly effective contraception methods include: intrauterine device (IUD), bilateral tubal ligation, vasectomy of partner, or sexual abstinence. Methods such as periodic abstinence (calendar method, basal body temperature, ovulation method), withdrawal, use of spermicides alone, lactational amenorrhea, or simultaneous use of male and female condoms are not considered effective contraception.
• Agree not to donate blood from the first dose until at least 4 weeks after the last dose of the investigational drugs.

You may not qualify if:

• Use of drug-metabolizing enzyme inducers or inhibitors (e.g., barbiturates) within 30 days prior to the first dose, or use of such medications within 10 days prior to the first dose.
• Participation in a bioequivalence study or other clinical trial involving investigational drugs within 6 months prior to the first dose.
• Whole blood donation within 8 weeks, plasma donation within 2 weeks, or blood transfusion within 4 weeks prior to the first dose.
• History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia surgery).
• Within 1 month prior to the first dose:
• Average alcohol consumption exceeding 21 drinks per week (1 drink = 50 mL soju, 250 mL beer, or 30 mL spirits)
• Smoking more than 20 cigarettes per day
• Any of the following conditions:
• History of hypersensitivity (including angioedema) to the investigational drug or its components
• Orthostatic hypotension
• Severe hepatic impairment
• Severe renal impairment
• Currently taking PDE5 inhibitors
• Currently taking CYP3A4 inhibitors
• Currently taking antihypertensive drugs

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

H plus Yangji Hospital

Seoul, Seoul, 08779, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 7, 2026
• Study Start: October 14, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-10

Locations

KR (1)