NCT05558150

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

September 23, 2022

Last Update Submit

June 26, 2023

Conditions

Drug Interaction Potentiation

Outcome Measures

Primary Outcomes (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

  • 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

Secondary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (6)

ilaprazole & aceclofenac 1

EXPERIMENTAL

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: IlaprazoleDrug: Aceclofenac

ilaprazole & aceclofenac 2

EXPERIMENTAL

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: IlaprazoleDrug: Aceclofenac

ilaprazole & aceclofenac 3

EXPERIMENTAL

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: IlaprazoleDrug: Aceclofenac

ilaprazole & aceclofenac 4

EXPERIMENTAL

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: IlaprazoleDrug: Aceclofenac

ilaprazole & aceclofenac 5

EXPERIMENTAL

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: IlaprazoleDrug: Aceclofenac

ilaprazole & aceclofenac 6

EXPERIMENTAL

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: IlaprazoleDrug: Aceclofenac

Interventions

IlaprazoleDRUG

Ilaprazole 10mg

Also known as: Noltec(the brand name)
ilaprazole & aceclofenac 1ilaprazole & aceclofenac 2ilaprazole & aceclofenac 3ilaprazole & aceclofenac 4ilaprazole & aceclofenac 5ilaprazole & aceclofenac 6
AceclofenacDRUG

Aceclofenac 100mg

Also known as: Airtal(the brand name)
ilaprazole & aceclofenac 1ilaprazole & aceclofenac 2ilaprazole & aceclofenac 3ilaprazole & aceclofenac 4ilaprazole & aceclofenac 5ilaprazole & aceclofenac 6

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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).
  • 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,
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

ilaprazoleaceclofenac

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
Model Details: Randomization, Open-label, Repeated administration, Crossover
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

November 10, 2022

Primary Completion

December 14, 2022

Study Completion

December 22, 2022

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)