- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05237297
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety After Co-administration of Ilaprazole and NSAID in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Sejun Oh, bachelor
- Phone Number: +82.2.570.3779
- Email: sjoh@ilyang.co.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults aged 19 or older and 55 or younger at the time of screening tests.
- Men weigh more than 55 kg and women weigh more than 50 kg.
Those who have a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2.
※ Body mass index (kg/m2) = Weight (kg)/[Height (m)]2
If participants are a woman, participants must apply to one of the following.
- Menopausal (no natural menstruation for at least 2 years)
- Surgical infertility (autonomous exudation or bilateral ovarian resection, intubation ligation, or other infertility)
- Men who have sexual relationship with women of child bearing potential must give consent to using contraceptive measures(condoms, spermicide, and menstrual cycle control) for at least 28 days after the final administration of clinical trial and clinical drugs (if the male test subject or female partner is infertile, the above contraception is unnecessary).
- A person who has heard sufficient explanation of this clinical trial and fully understood it, voluntarily decided to participate, and agreed in writing to comply with precautions.
Exclusion Criteria:
- A person with a history of mental illness or illness corresponding to clinically significant hepatobiliary tract (hepatic liver disorder, kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system (bronchial asthma, etc.), urinary system, digestive system, endocrine blood and tumor, cardiovascular system (severe high blood pressure, heart failure, etc.).
- Active peptic ulcer/bleeding or a person with a medical history.
- A person who tends to bleed or have a blood clotting disorder.
- Patients with a history of gastrointestinal bleeding or perforation due to NSAID treatment in the past.
- Those with a history of gastrointestinal diseases (Crohn's disease, ulcerative colitis, etc.) or surgery (except for simple appendectomy or hernia surgery) that can affect the absorption of drugs.
- Person with a history of significant drug hypersensitivity reactions to the ingredients and additives of clinical trial drugs. In particular, NSAIDs and aspirin such as Yellow No. 4 (Tartrazine), Yellow No. 5 (Sunset Yellow FCF), sulfonamide, ilaprazole and naproxen, aceclofenac, celecoxib, diclofenac, etc.
- A person with a history of asthma, rhinitis, and nasal polyps due to aspirin or other NSAIDs (including COX-2 inhibitors).
- Those with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption.
A person who was judged to be inappropriate as a test subject in a screening test conducted within 28 days before the first administration date of the clinical trial drug.
- In the case of > 1.25 times the upper limit of AST and ALT normal range in the blood,
- When the potassium concentration in the blood exceeds 5.5 mEq/L,
- Estimated Global Film Rate (eGFR) <60 mL/min/1.73 m2 using the Modification of Diet in Regular Disease (MDRD) formula
- Immunology and serology tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test) result are positive factors.
- After resting for more than 5 minutes, systolic blood pressure >150 mmHg or << in vital signs measured at the seat> Those who showed values corresponding to 90 mmHg, dilator blood pressure >100 mmHg, or <50 mmHg.
- A person who has a history of drug abuse or has tested positive in a urine drug screening test within one year of screening.
If the tester determines that the following drugs, excluding topical drugs without significant systemic absorption, may affect this test or affect the safety of the test subject within the relevant period,
- In the case of taking a prescription drug or herbal medicine within 14 days prior to the first administration date of the clinical trial drug,
- In the case of taking general medicines including health foods and vitamin preparations within 7 days prior to the first administration of clinical trial drugs,
- A person who took drugs such as barbital drugs and other drugs inducing and inhibiting drugs within 30 days prior to the first administration of clinical trial drugs.
- A person who continuously smoked excessively or consumed caffeine or alcohol (caffeine: >5 cups/day, alcohol: >210 g/week, tobacco: >10 g/day) or who cannot stop smoking, caffeine and alcohol consumption during each hospitalization period.
- A person who has consumed grapefruit-containing food within 7 days prior to the first administration date of clinical trial drugs or cannot be prohibited from taking it during the clinical trial period.
- A person who participated in another clinical trial within 180 days prior to the first administration date of the clinical trial drug and received the clinical trial drug (in the case of biological agents, it may be based on an extended period considering a half-life).
- A person who donated whole blood within 60 days prior to the first administration date of clinical trial drugs or donated component blood within 30 days.
- A person who received a blood transfusion within 30 days prior to the first administration date of the clinical trial drug.
- Pregnant or lactating women.
- A person who determines that the tester is inappropriate to participate in clinical trials due to other reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ilaprazole & naproxen
Period 1 : Ilaprazole 10mg/tab, one a day, 5 days Period 2 : naproxen 500mg/tab, twice a day, 4 days and naproxen 500mg/tab, one a day one at the 5 day Period 3 : Ilaprazole 10mg/tab, one a day, 5 days + naproxen 500mg/tab, twice a day, 5 days |
Ilaprazole 10mg
Other Names:
Naproxen 500mg
Other Names:
|
Active Comparator: ilaprazole & aceclofenac
Period 1 : Ilaprazole 10mg/tab, one a day, 5 days Period 2 : aceclofenac 100mg/tab, twice a day, 4 days and aceclofenac 100mg/tab, one a day one at the 5 day Period 3 : Ilaprazole 10mg/tab, one a day, 5 days + aceclofenac 100mg/tab, twice a day, 5 days |
Ilaprazole 10mg
Other Names:
Aceclofenac 100mg
Other Names:
|
Active Comparator: ilaprazole & celecoxib
Period 1 : Ilaprazole 10mg/tab, one a day, 5 days Period 2 : celecoxib 200mg/cap, twice a day, 4 days and celecoxib 200mg/cap, one a day one at the 5 day Period 3 : Ilaprazole 10mg/tab, one a day, 5 days + celecoxib 200mg/cab, twice a day, 5 days |
Ilaprazole 10mg
Other Names:
Celecoxib 200mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, naproxen Cmax,ss(Maximum concentration of drug in plasma at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 1
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, naproxen AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 2
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, aceclofenac Cmax,ss(Maximum concentration of drug in plasma at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 2
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, aceclofenac AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 3
Time Frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, celecoxib Cmax,ss(Maximum concentration of drug in plasma at steady state)
|
Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 3
Time Frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, celecoxib AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state)
|
Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, naproxen Tmax,ss(Time to maximum plasma concentration at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 1.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, naproxen CLss/F(Apparent clearance of drug in plasma at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 1.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, naproxen Vdss/F(Apparent volume of distribution at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 1.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, naproxen Cmin,ss(Minimum concentration of drug in plasma at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 1.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, naproxen fluctuation
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 2.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, aceclofenac Tmax,ss(Time to maximum plasma concentration at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 2.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, aceclofenac CLss/F(Apparent clearance of drug in plasma at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 2.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, aceclofenac Vdss/F(Apparent volume of distribution at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 2.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, aceclofenac Cmin,ss(Minimum concentration of drug in plasma at steady state)
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 2.
Time Frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, aceclofenac fluctuation
|
Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 3.
Time Frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, celecoxib Tmax,ss(Time to maximum plasma concentration at steady state)
|
Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 3.
Time Frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, celecoxib CLss/F(Apparent clearance of drug in plasma at steady state)
|
Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 3.
Time Frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, celecoxib Vdss/F(Apparent volume of distribution at steady state)
|
Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 3.
Time Frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, celecoxib Cmin,ss(Minimum concentration of drug in plasma at steady state)
|
Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Part 3.
Time Frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
ilaprazole, celecoxib fluctuation
|
Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Minsoo Park, PhD, Severance Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Gout Suppressants
- Celecoxib
- Naproxen
- Aceclofenac
Other Study ID Numbers
- IL49NS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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