Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole

NCT05237297 | Completed Phase 1

• 1 other identifier: IL49NS01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the pharmacokinetic drug interactions and safety after co-administration of ilaprazole and NSAID in healthy adults.

Conditions

Drug Interaction Potentiation

Outcome Measures

Primary Outcomes (6)

• Part 1

  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

  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

  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

  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

  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

  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 Outcomes (15)

• Part 1.

  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.

  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.

  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.

  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.

  Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours

Study Arms (3)

ilaprazole & naproxen

ACTIVE COMPARATOR

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

Drug: Ilaprazole; Drug: Naproxen

ilaprazole & aceclofenac

ACTIVE COMPARATOR

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

Drug: Ilaprazole; Drug: Aceclofenac

ilaprazole & celecoxib

ACTIVE COMPARATOR

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

Drug: Ilaprazole; Drug: Celecoxib

Interventions

Ilaprazole DRUG

Ilaprazole 10mg

Also known as: Noltec(the brand name)

ilaprazole & aceclofenac; ilaprazole & celecoxib; ilaprazole & naproxen

Naproxen DRUG

Naproxen 500mg

Also known as: Naxen-F(the brand name)

ilaprazole & naproxen

Aceclofenac DRUG

Aceclofenac 100mg

Also known as: Airtal(the brand name)

ilaprazole & aceclofenac

Celecoxib DRUG

Celecoxib 200mg

Also known as: Celebrex(the brand name)

ilaprazole & celecoxib

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

ilaprazole; Naproxen; aceclofenac; Celecoxib

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Minsoo Park, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomization, Open-label, Repeated administration, Crossover

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 14, 2022
• Study Start: February 17, 2022
• Primary Completion: July 13, 2022
• Study Completion: July 27, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)