A clinical trial to evaluate the effects of enzyme inhibitor on the concentration of Venlafaxine and O-desmethylvenlafaxine (ODV) according to genotypes in healthy subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0008645
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
Healthy adults aged 19 or older but not exceeding 50 years at the time of the screening test.
Individuals with a weight of 55.0 kg or more and 90.0 kg or less, and a body mass index (BMI) between 18.5 and 30.0.
• BMI (kg/m2) = Weight (kg) / {Height (m)}2
Individuals who are normal metabolizers (CYP2C19 *1/*1) based on CYP2C19 genotyping.
Individuals who are normal or intermediate metabolizers based on CYP2D6 genotyping.
Individuals with clinically significant diseases or a medical history related to the liver, kidneys, nervous system, immune system, respiratory system, endocrine system, blood, tumors, cardiovascular diseases, or mental disorders (such as mood disorders, obsessive-compulsive disorder) or with a past medical history in these areas.
Individuals with a history of suicidal behavior and/or persistent suicidal ideation as assessed by C-SSRS (Columbia-Suicide Severity Rating Scale) evaluation.
Individuals with a known hypersensitivity reaction to investigational drugs or the components of investigational drugs, or with a significant history of hypersensitivity reactions in a clinical context.
Individuals with the following results in the screening tests:
Those whose aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels exceed 1.5 times the upper limit of the normal range in clinical laboratory tests.
Those with positive results in serum tests for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis.
Those with systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg.
Individuals with a history of drug abuse or who tested positive for abused drugs in urine drug screening tests.
Individuals who have taken any prescription or herbal medicine within 2 weeks prior to the scheduled first administration date, or any over-the-counter (OTC) medication, dietary supplements, or vitamin preparations within 1 week prior to the scheduled first administration date (except when deemed appropriate by the investigator's judgment), or those expected to take such medications.
Individuals who received a live vaccine within 4 weeks prior to the scheduled first administration date or other vaccines within 2 weeks prior to the scheduled first administration date.
Individuals who have taken drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month prior to the scheduled first administration date.
Individuals who have participated in another clinical trial or bioequivalence study and received an investigational drug or a bioequivalence study drug within 6 months prior to the scheduled first administration date.
Individuals who have donated whole blood within 2 months or donated blood components within 1 month prior to the scheduled first administration date, or received a blood transfusion within 1 month prior to the scheduled first administration date.
Individuals who consume alcohol continuously (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or are unable to abstain from alcohol during the clinical trial period.
Individuals who cannot refrain from consuming grapefruit-containing foods from 3 days before the scheduled first administration of the investigational drug until the end of the clinical trial period.
Individuals who do not use medically acceptable contraceptive methods during the pre-trial period, including:
Use of an intrauterine device (copper IUD, hormone-releasing intrauterine system) in the spouse/partner with documented failure rates of contraception.
Concurrent use of a barrier method of contraception (male or female) with oral contraceptives or non-oral hormonal contraceptives.
Self or partner's surgical procedures (vasectomy, tubal ligation/occlusion, hysterectomy, etc.).
Cervical cap or diaphragm use along with male condoms for contraception.
Pregnant or lactating women.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of pharmacokientics of venlafaxine and o-desmethylvenlafaxine before and after coadministration of paroxetine
- Secondary Outcome Measures
Name Time Method safety parameters