Clinical trial NCT06568133: Drug-drug Interaction Study Between UIC201603, and UIC201604
Official title: An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201603 and UIC201604 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201603 and UIC201604 in healthy volunteers


Eligibility criteria: Inclusion Criteria:

1. Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
2. Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
3. Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
4. Subjects able to read and understand a written informed consent, and willing to participate in the study.
5. For women, those who are confirmed not to be pregnant during a health examination

Exclusion Criteria:

1. Clinically significant, liver, kidney, nervous system, respiratory system, blood/tumor, urinary system, Mental disorders, especially cardiovascular diseases (e.g. hypertension, angina pectoris, heart failure, myocardial infarction, etc.) Those who have or have a history of diseases related to the endocrine system (diabetes, hyperlipidemia, etc.)
2. Bleeding (hemophilia, capillary fragility, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.) or such predispositions (active peptic ulcer, hemorrhagic stroke within the past 6 months, surgery within the past 3 months, proliferative diabetic retinopathy, uncontrolled Patients with high blood pressure)
3. Patients with atrial or ventricular displacement, patients with atrial fibrillation or flutter, ventricular tachycardia, ventricular fibrillation, or Patients with multifocal ventricular ectopic beats and patients with prolonged QT interval
4. Gastrointestinal diseases that may affect the absorption of investigational drugs (Crohn's disease, ulcers) acute or chronic pancreatitis, etc.) or gastrointestinal surgery (however, simple appendectomy or Those with a history of hernia surgery (excluding hernia surgery)
5. Those with a history of hypersensitivity to Cilostazol or other antiplatelet agents,
6. Same series as rosuvastatin, atorvastatain, simvastatin, etc. (HMG-CoA Hypersensitivity reaction to the components of reductase inhibitor or clinically significant Those with a history of hypersensitivity reaction
7. Galactose intolerance, Lapp lactase deficiency lactose deficiency or glucose-galactose malabsorption People with genetic problems such as malabsorption
8. If PT and aPTT are outside the allowable range (diagnostic laboratory reference values are 11-15 sec, respectively, 22.4-40.4 sec)
9. Vital signs show systolic blood pressure ≥ 140 mmHg or \< 90 mmHg, diastolic blood pressure ≥ 95 Either mmHg or \<60 mmHg, pulse rate ≥100 beats/min. Those who showed included figures
10. Those with high-density lipoprotein (HDL-cholesterol) less than 35 mg/dL
11. Those whose serum potassium concentration is less than 3.4 mEq/L or more than 5.5 mEq/L
12. Have a history of muscle disease or a personal or family history of hereditary muscle abnormalities ruler
13. Patients with biliary obstructive disease
14. Unexplained persistent elevation of serum transaminases or three times the upper limit of normal Patients with active liver disease including excess serum transaminase elevations
15. Patients with severe renal impairment (creatinine clearance calculated by the Cockcroft-Gault equation is 30 Those with less than mL/min)
16. Those with a history of drug abuse or a positive drug abuse test
17. Induction of drug metabolizing enzymes such as barbiturates within 1 month before the first administration date and Those who take suppressive drugs or drink excessively
18. Those who have taken any prescription medicine or herbal medicine within 2 weeks before the first medication date, or any over-the-counter medicine (OTC medicine) or vitamin supplement within 10 days (except, Depending on the investigator's judgment, you may participate in the clinical trial if other conditions are reasonable. has exist)
19. Participating in another clinical trial or bioequivalence test within 3 months before the first administration date Person who administered clinical trial drug
20. Donate whole blood within 2 months or component blood within 1 month before the first dose. or received a blood transfusion within 1 month before the first dose
21. For women, pregnant/nursing or currently using a medically acceptable form of contraception. Those who are not using contraception or are unable to maintain contraception during the clinical trial period
22. Clinical test performance The investigator may not conduct a clinical trial due to test results or other reasons. Those judged unsuitable for participation

Primary outcomes:
measure: Plasma pharmacokinetics(AUCss,τ) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)
timeFrame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
measure: Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)
timeFrame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
measure: Plasma pharmacokinetics(AUCss,τ) of Rosuvastatin
timeFrame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
measure: Plasma pharmacokinetics(Css,max) of Rosuvastatin
timeFrame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National University Hospital
name: Janghee Hong, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: