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AzTrials

HealthyPhase 1NCT06568133

Drug-drug Interaction Study Between UIC201603, and UIC201604

A Phase 1 study testing UIC201603 and co-administration of UIC201603 and UIC201604 and UIC201604 and co-administration of UIC201603 and UIC201604 in people with Healthy, run by Korea United Pharm. Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
UIC201603 and co-administration of UIC201603 and UIC201604 and UIC201604 and co-administration of UIC201603 and UIC201604
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteSouth Korea
Study dates
15 Mar 2017to 7 Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)
  • Those with a history of drug abuse or a positive drug abuse test
  • 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
  • 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)
  • Participating in another clinical trial or bioequivalence test within 3 months before the first administration date Person who administered clinical trial drug
  • 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
  • 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
  • Clinical test performance The investigator may not conduct a clinical trial due to test results or other reasons. Those judged unsuitable for participation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungnam National University Hospital

    Daejeon

Other trials in South Korea

About this study

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

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
Being tested
UIC201603 and co-administration of UIC201603 and UIC201604, UIC201604 and co-administration of UIC201603 and UIC201604

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UIC201603 and co-administration of UIC201603 and UIC201604Drug

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

  • UIC201604 and co-administration of UIC201603 and UIC201604Drug

    • 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
Study groups in NCT06568133
Study groupRoleWhat they receive
Treatment AExperimentalUIC201603 and co-administration of UIC201603 and UIC201604
Receives: Drug: UIC201603 and co-administration of UIC201603 and UIC201604
Treatment BExperimentalUIC201604 and co-administration of UIC201603 and UIC201604
Receives: Drug: UIC201604 and co-administration of UIC201603 and UIC201604

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

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

    Maximum concentration of drug in serum at steady state

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

  3. Plasma pharmacokinetics(AUCss,τ) of Rosuvastatin

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

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

  4. Plasma pharmacokinetics(Css,max) of Rosuvastatin

    Maximum concentration of drug in serum at steady state

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start15 Mar 2017
  3. Primary completion4 Jul 2017
  4. Study completion7 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06568133
Sponsor's protocol ID
KUP-UI022-101
Status last verified
Jul 2018
First submitted
23 Jul 2024
Last updated
23 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39487337

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UIC201603 and co-administration of UIC201603 and UIC201604 and UIC201604 and co-administration of UIC201603 and UIC201604 in people with Healthy, run by Korea United Pharm. Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma pharmacokinetics(AUCss,τ) of Cilostazol and Active metabolites(OPC-13015, OPC-13213) (time frame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06568133, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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Clinical Trial NCT06568133 | AzTrials