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

Il-Yang Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07322991

IY-DDI2025

Details and patient eligibility

About

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

Full description

The study is an Open-label, Phase I, drug-drug interaction study.

Enrollment: 43 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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
  • 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 design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Part A

Experimental group

Description:

IY001 -\> IY001 + IY002

Treatment:

Drug: IY002(Tamsulosin)

Drug: IY001(Finasteride)

Part B

Experimental group

Description:

IY002 -\> IY001 + IY002

Treatment:

Drug: IY002(Tamsulosin)

Drug: IY001(Finasteride)