Drug-drug Interaction Study Between UIC201603, and UIC201604

NCT06568133 | Completed Phase 1

• 1 other identifier: KUP-UI022-101
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Plasma pharmacokinetics(AUCss,τ) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)

  Area under the serum drug concentration-time curve within a dosing interval at steady state

  Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h

• Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)

  Maximum concentration of drug in serum at steady state

  Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h

• Plasma pharmacokinetics(AUCss,τ) of Rosuvastatin

  Area under the serum drug concentration-time curve within a dosing interval at steady state

  Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h

• Plasma pharmacokinetics(Css,max) of Rosuvastatin

  Maximum concentration of drug in serum at steady state

  Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h

Study Arms (2)

Treatment A

EXPERIMENTAL

UIC201603 and co-administration of UIC201603 and UIC201604

Drug: UIC201603 and co-administration of UIC201603 and UIC201604

Treatment B

EXPERIMENTAL

UIC201604 and co-administration of UIC201603 and UIC201604

Drug: UIC201604 and co-administration of UIC201603 and UIC201604

Interventions

UIC201603 and co-administration of UIC201603 and UIC201604 DRUG

* UIC201603 2 Caps/day for 7 days * Wash out 7 days * UIC201603 2 Caps/day + UIC201604 1 Tabs/day for 7 days

Treatment A

UIC201604 and co-administration of UIC201603 and UIC201604 DRUG

* UIC201604 1 Tabs/day for 7 days * Wash out 7 days * UIC201603 2 Caps/day + UIC201604 1 Tabs/day for 7 daysadministration of UIC201603 and UIC201604

Treatment B

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)
• 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)
• 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
• 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)
• Those with a history of hypersensitivity to Cilostazol or other antiplatelet agents,
• 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
• Galactose intolerance, Lapp lactase deficiency lactose deficiency or glucose-galactose malabsorption People with genetic problems such as malabsorption
• If PT and aPTT are outside the allowable range (diagnostic laboratory reference values are 11-15 sec, respectively, 22.4-40.4 sec)
• 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
• Those with high-density lipoprotein (HDL-cholesterol) less than 35 mg/dL
• Those whose serum potassium concentration is less than 3.4 mEq/L or more than 5.5 mEq/L
• Have a history of muscle disease or a personal or family history of hereditary muscle abnormalities ruler
• Patients with biliary obstructive disease
• Unexplained persistent elevation of serum transaminases or three times the upper limit of normal Patients with active liver disease including excess serum transaminase elevations
• Patients with severe renal impairment (creatinine clearance calculated by the Cockcroft-Gault equation is 30 Those with less than mL/min)

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

Related Publications (1)

• Kim DH, Hong JH, Jung WT, Nam KY, Roh JS, Lee HJ, Moon J, Kim KY, Jung JG, Sunwoo J. Pharmacokinetic Drug-Drug Interaction between Cilostazol and Rosuvastatin in Healthy Participants. Am J Cardiovasc Drugs. 2025 Mar;25(2):267-276. doi: 10.1007/s40256-024-00686-w. Epub 2024 Nov 2.

  PMID: 39487337 DERIVED

Study Officials

• Janghee Hong, M.D.,Ph.D

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 23, 2024
• Study Start: March 15, 2017
• Primary Completion: July 4, 2017
• Study Completion: February 7, 2018
• Last Updated: August 23, 2024

Record last verified: 2018-07

Locations

KR (1)