Healthy Adult MalePhase 1NCT07322991
Study to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.
A Phase 1 study testing IY001(Finasteride) and IY002(Tamsulosin) in people with Healthy Adult Male, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- IY001(Finasteride) and IY002(Tamsulosin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Oct 2025to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 21Show fewer
- 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
- Currently taking alpha-1 blockers
- History of micturition syncope
- Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Hypersensitivity or allergy to Sunset Yellow FCF (Yellow No. 5) contained in the drug
- History of clinically significant psychiatric disorders.
- Any other condition that the principal investigator (or delegated sub-investigator) deems makes the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial With an Open-label, Single-agent Repeated Dosing Followed by Combined Repeated Dosing Design to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.
The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males.
Read the detailed description
The study is an Open-label, Phase I, drug-drug interaction study.
- Conditions
- Healthy Adult Male
- Being tested
- IY001(Finasteride), IY002(Tamsulosin)
- Keywords
- Urology, Drug-Drug Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | IY001 -> IY001 + IY002 Receives: Drug: IY001(Finasteride); Drug: IY002(Tamsulosin) |
| Part B | Experimental | IY002 -> IY001 + IY002 Receives: Drug: IY001(Finasteride); Drug: IY002(Tamsulosin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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)
Time to reach the maximum plasma concentration of finasteride measured from plasma samples collected at pre-dose and multiple post-dose time points on Days 3 and 8.
Measured: Days 3 and 8
Finasteride Elimination Half-Life at Steady State (t1/2,ss)
The elimination half-life of finasteride calculated using plasma concentrations from serial blood samples collected up to 24 hours post-dose on Days 3 and 8.
Measured: Days 3 and 8
Finasteride Apparent Clearance at Steady State (CLss/F)
Apparent clearance of finasteride derived from plasma concentration-time data obtained from serial blood sampling on Days 3 and 8.
Measured: Days 3 and 8
Finasteride Minimum Plasma Concentration at Steady State (Cmin,ss)
Minimum plasma concentration measured from pre-dose (0 hour) samples collected on Days 1, 2, 7, and 8.
Measured: Days 1, 2, 7, and 8
Finasteride Average Plasma Concentration at Steady State (Cav,ss)
Average plasma concentration calculated over the dosing interval from serial samples collected on Days 3 and 8.
Measured: Days 3 and 8
Finasteride Accumulation Ratio (R)
Ratio of plasma concentrations comparing steady state (Day 8) to earlier dosing period (Day 3).
Measured: Days 3 and 8
Finasteride Peak-Trough Fluctuation (PTF)
Fluctuation between peak (Cmax) and trough (Cmin) plasma concentrations calculated from serial sampling on Days 3 and 8.
Measured: Days 3 and 8
Tamsulosin Time to Maximum Plasma Concentration at Steady State (Tmax,ss)
Time to reach the maximum plasma concentration of tamsulosin measured from plasma samples collected at pre-dose and multiple post-dose time points on Days 5 and 8.
Measured: Days 5 and 8
Tamsulosin Elimination Half-Life at Steady State (t1/2,ss)
Elimination half-life calculated from plasma concentrations obtained up to 24 hours post-dose on Days 5 and 8.
Measured: Days 5 and 8
Tamsulosin Apparent Clearance at Steady State (CLss/F)
Apparent clearance derived from plasma concentration-time data on Days 5 and 8.
Measured: Days 5 and 8
Tamsulosin Minimum Plasma Concentration at Steady State (Cmin,ss)
Minimum plasma concentration measured from pre-dose samples collected on Days 1, 4, 7, and 8.
Measured: Days 1, 4, 7, and 8
Tamsulosin Average Plasma Concentration at Steady State (Cav,ss)
Average plasma concentration over dosing interval calculated from serial samples on Days 5 and 8.
Measured: Days 5 and 8
Tamsulosin Accumulation Ratio (R)
Ratio of plasma concentrations comparing steady state (Day 8) to earlier dosing period (Day 5).
Measured: Days 5 and 8
Tamsulosin Peak-Trough Fluctuation (PTF)
Fluctuation between peak (Cmax) and trough (Cmin) plasma concentrations from serial sampling on Days 5 and 8.
Measured: Days 5 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start14 Oct 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322991
- Sponsor's protocol ID
- IY-DDI2025
- Status last verified
- Oct 2025
- First submitted
- 11 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial With an Open-label, Single-agent Repeated Dosing Followed by Combined Repeated Dosing Design to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.
- ClinicalTrials.gov ID
- NCT07322991
- Acronym / sponsor ID
- IY-DDI2025
- Conditions
- Healthy Adult Male
- Keywords
- Urology, Drug-Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males.
Detailed description
The study is an Open-label, Phase I, drug-drug interaction study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: IY001(Finasteride), Drug: IY002(Tamsulosin)IY001 -> IY001 + IY002 |
| Part B | Experimental | Drug: IY001(Finasteride), Drug: IY002(Tamsulosin)IY002 -> IY001 + IY002 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IY001(Finasteride)Subjects will receive IY001 once daily for 3 days, followed by co-administration of IY001 and IY002 once daily for 5 days. | Drug | Part A, Part B |
| IY002(Tamsulosin)Subjects will receive IY002 once daily for 5 days, followed by co-administration of IY001 and IY002 once daily for 3 days. | Drug | Part A, Part B |
Primary outcome
Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)
The total drug exposure of finasteride over the dosing interval at steady state.
Finasteride Maximum Plasma Concentration at steady state (Cmax,ss)
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)
The peak plasma concentration of finasteride observed at steady state.
Tamsulosin Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)
The total drug exposure of tamsulosin over the dosing interval at steady state.
Tamsulosin Maximum Plasma Concentration at steady state (Cmax,ss)
Time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)
The peak plasma concentration of tamsulosin observed at steady state.
14 secondary outcomes
Finasteride Time to Maximum Plasma Concentration at steady state (Tmax,ss)
Time frame: Days 3 and 8
Finasteride Elimination Half-Life at Steady State (t1/2,ss)
Time frame: Days 3 and 8
Finasteride Apparent Clearance at Steady State (CLss/F)
Time frame: Days 3 and 8
Finasteride Minimum Plasma Concentration at Steady State (Cmin,ss)
Time frame: Days 1, 2, 7, and 8
Finasteride Average Plasma Concentration at Steady State (Cav,ss)
Time frame: Days 3 and 8
Finasteride Accumulation Ratio (R)
Time frame: Days 3 and 8
Finasteride Peak-Trough Fluctuation (PTF)
Time frame: Days 3 and 8
Tamsulosin Time to Maximum Plasma Concentration at Steady State (Tmax,ss)
Time frame: Days 5 and 8
Tamsulosin Elimination Half-Life at Steady State (t1/2,ss)
Time frame: Days 5 and 8
Tamsulosin Apparent Clearance at Steady State (CLss/F)
Time frame: Days 5 and 8
Tamsulosin Minimum Plasma Concentration at Steady State (Cmin,ss)
Time frame: Days 1, 4, 7, and 8
Tamsulosin Average Plasma Concentration at Steady State (Cav,ss)
Time frame: Days 5 and 8
Tamsulosin Accumulation Ratio (R)
Time frame: Days 5 and 8
Tamsulosin Peak-Trough Fluctuation (PTF)
Time frame: Days 5 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IY001(Finasteride) and IY002(Tamsulosin) in people with Healthy Adult Male, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss) (time frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.