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Study to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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.

NCT07322991•Il-Yang Pharm. Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

19 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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
+11 more criteria

Locations (1)

H plus Yangji Hospital

Seoul, Seoul, South Korea

Key Dates

Start Date

October 14, 2025

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

Healthy Adult Male

Interventions

IY001(Finasteride)

DRUG

IY002(Tamsulosin)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Evaluation of MTX-463 Administered Subcutaneously in Healthy Adult Males

Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions

Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

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