Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Ilaprazole and Aceclofenac

Sponsor
Il-Yang Pharm. Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05558150
Collaborator
(none)
24
1
6
4.9
4.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety After Co-administration of Ilaprazole and Aceclofenac in Healthy Adults
Anticipated Study Start Date :
Nov 11, 2022
Anticipated Primary Completion Date :
Jan 10, 2023
Anticipated Study Completion Date :
Apr 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ilaprazole & aceclofenac 1

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
Ilaprazole 10mg
Other Names:
  • Noltec(the brand name)
  • Drug: Aceclofenac
    Aceclofenac 100mg
    Other Names:
  • Airtal(the brand name)
  • Experimental: ilaprazole & aceclofenac 2

    Period 1 : Ilaprazole 10mg/tab, one a day, 5 days + aceclofenac 100mg/tab, twice a day, 5 days Period 2 : Ilaprazole 10mg/tab, one a day, 5 days Period 3 : aceclofenac 100mg/tab, twice a day, 4 days and aceclofenac 100mg/tab, one a day one at the 5 day

    Drug: Ilaprazole
    Ilaprazole 10mg
    Other Names:
  • Noltec(the brand name)
  • Drug: Aceclofenac
    Aceclofenac 100mg
    Other Names:
  • Airtal(the brand name)
  • Experimental: ilaprazole & aceclofenac 3

    Period 1 : aceclofenac 100mg/tab, twice a day, 4 days and aceclofenac 100mg/tab, one a day one at the 5 day Period 2 : Period 3 : Ilaprazole 10mg/tab, one a day, 5 days + aceclofenac 100mg/tab, twice a day, 5 days Period 3 : Ilaprazole 10mg/tab, one a day, 5 days

    Drug: Ilaprazole
    Ilaprazole 10mg
    Other Names:
  • Noltec(the brand name)
  • Drug: Aceclofenac
    Aceclofenac 100mg
    Other Names:
  • Airtal(the brand name)
  • Experimental: ilaprazole & aceclofenac 4

    Period 1 : Ilaprazole 10mg/tab, one a day, 5 days Period 2 : Ilaprazole 10mg/tab, one a day, 5 days + aceclofenac 100mg/tab, twice a day, 5 days Period 3 : aceclofenac 100mg/tab, twice a day, 4 days and aceclofenac 100mg/tab, one a day one at the 5 day

    Drug: Ilaprazole
    Ilaprazole 10mg
    Other Names:
  • Noltec(the brand name)
  • Drug: Aceclofenac
    Aceclofenac 100mg
    Other Names:
  • Airtal(the brand name)
  • Experimental: ilaprazole & aceclofenac 5

    Period 1 : Ilaprazole 10mg/tab, one a day, 5 days + aceclofenac 100mg/tab, twice 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

    Drug: Ilaprazole
    Ilaprazole 10mg
    Other Names:
  • Noltec(the brand name)
  • Drug: Aceclofenac
    Aceclofenac 100mg
    Other Names:
  • Airtal(the brand name)
  • Experimental: ilaprazole & aceclofenac 6

    Period 1 : aceclofenac 100mg/tab, twice a day, 4 days and aceclofenac 100mg/tab, one a day one at the 5 day Period 2 : Ilaprazole 10mg/tab, one a day, 5 days Period 3 : Ilaprazole 10mg/tab, one a day, 5 days + aceclofenac 100mg/tab, twice a day, 5 days

    Drug: Ilaprazole
    Ilaprazole 10mg
    Other Names:
  • Noltec(the brand name)
  • Drug: Aceclofenac
    Aceclofenac 100mg
    Other Names:
  • Airtal(the brand name)
  • Outcome Measures

    Primary Outcome Measures

    1. ilaprazole, aceclofenac Cmax,ss [Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours]

      Maximum concentration of drug in plasma at steady state

    2. ilaprazole, aceclofenac AUCtau,ss [Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours]

      Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state

    Secondary Outcome Measures

    1. ilaprazole, aceclofenac Tmax,ss [Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours]

      Time to maximum plasma concentration at steady state

    2. ilaprazole, aceclofenac CLss/F [Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours]

      Apparent clearance of drug in plasma at steady state

    3. ilaprazole, aceclofenac Vdss/F [Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours]

      Apparent volume of distribution at steady state

    4. ilaprazole, aceclofenac Cmin,ss [Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours]

      Minimum concentration of drug in plasma at steady state

    5. 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]

      fluctuation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Healthy adults aged 19 or older and 55 or younger at the time of screening tests.

    2. Men weigh more than 55 kg and women weigh more than 50 kg.

    3. 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

    1. 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)

    1. 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).

    2. 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:
    1. 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.).

    2. Active peptic ulcer/bleeding or a person with a medical history.

    3. A person who tends to bleed or have a blood clotting disorder.

    4. Patients with a history of gastrointestinal bleeding or perforation due to NSAID treatment in the past.

    5. 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.

    6. 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.

    7. A person with a history of asthma, rhinitis, and nasal polyps due to aspirin or other NSAIDs (including COX-2 inhibitors).

    8. 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.

    1. A person who has a history of drug abuse or has tested positive in a urine drug screening test within one year of screening.

    2. 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.

    1. 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.

    2. 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.

    3. 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).

    4. 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.

    5. A person who received a blood transfusion within 30 days prior to the first administration date of the clinical trial drug.

    6. Pregnant or lactating women.

    7. A person who determines that the tester is inappropriate to participate in clinical trials due to other reasons.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Il-Yang Pharm. Co., Ltd.

    Investigators

    • Principal Investigator: Minsoo Park, PhD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Il-Yang Pharm. Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05558150
    Other Study ID Numbers:
    • REIL49NS01
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Sep 28, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 28, 2022