Drug Interaction PotentiationPhase 1NCT05558150

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

A Phase 1 study testing Ilaprazole and Aceclofenac in people with Drug Interaction Potentiation, run by Il-Yang Pharm. Co., Ltd. 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

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

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Drug Interaction Potentiation
What is being tested?: Ilaprazole and Aceclofenac
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteSouth Korea
Study dates: 10 Nov 2022to 22 Dec 2022
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

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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.

Who cannot join

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.

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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,
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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital
Seoul, 03722

Other trials in South Korea

About this study

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

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

Conditions: Drug Interaction Potentiation
Being tested: Ilaprazole, Aceclofenac

What participants receive

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

IlaprazoleDrug
Also called Noltec(the brand name)
Ilaprazole 10mg
AceclofenacDrug
Also called Airtal(the brand name)
Aceclofenac 100mg

Study groups in NCT05558150
Study group	Role	What they receive
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 Receives: Drug: Ilaprazole; Drug: 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 Receives: Drug: Ilaprazole; Drug: 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 Receives: Drug: Ilaprazole; Drug: 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 Receives: Drug: Ilaprazole; Drug: 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 Receives: Drug: Ilaprazole; Drug: 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 Receives: Drug: Ilaprazole; Drug: Aceclofenac

What is being measured

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

ilaprazole, aceclofenac Cmax,ss
Maximum concentration of drug in plasma at steady state
Measured: 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
Measured: 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
Time to maximum plasma concentration at steady state
Measured: 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
Measured: 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
Measured: 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
Measured: 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
fluctuation
Measured: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours

Timeline

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

10 Nov 202222 Dec 2022

First posted28 Sep 2022
Study start10 Nov 2022
Primary completion14 Dec 2022
Study completion22 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug Interaction PotentiationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomization, Open-label, Repeated administration, Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05558150
Sponsor's protocol ID: REIL49NS01
Status last verified: Jun 2023
First submitted: 23 Sep 2022
Last updated: 28 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05558150
Acronym / sponsor ID: REIL49NS01
Conditions: Drug Interaction Potentiation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Nov 2022 (actual)
Primary completion: 14 Dec 2022 (actual)
Study completion: 22 Dec 2022 (actual)
First posted: 28 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: Randomization, Open-label, Repeated administration, Crossover

Arm	Type	Receives
ilaprazole & aceclofenac 1	Experimental	Drug: Ilaprazole, Drug: AceclofenacPeriod 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 & aceclofenac 2	Experimental	Drug: Ilaprazole, Drug: AceclofenacPeriod 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
ilaprazole & aceclofenac 3	Experimental	Drug: Ilaprazole, Drug: AceclofenacPeriod 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
ilaprazole & aceclofenac 4	Experimental	Drug: Ilaprazole, Drug: AceclofenacPeriod 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
ilaprazole & aceclofenac 5	Experimental	Drug: Ilaprazole, Drug: AceclofenacPeriod 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
ilaprazole & aceclofenac 6	Experimental	Drug: Ilaprazole, Drug: AceclofenacPeriod 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

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (25 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IlaprazoleAlso: Noltec(the brand name)Ilaprazole 10mg	Drug	ilaprazole & aceclofenac 1, ilaprazole & aceclofenac 2, ilaprazole & aceclofenac 3, ilaprazole & aceclofenac 4, ilaprazole & aceclofenac 5, ilaprazole & aceclofenac 6
AceclofenacAlso: Airtal(the brand name)Aceclofenac 100mg	Drug	ilaprazole & aceclofenac 1, ilaprazole & aceclofenac 2, ilaprazole & aceclofenac 3, ilaprazole & aceclofenac 4, ilaprazole & aceclofenac 5, ilaprazole & aceclofenac 6

Primary outcome

ilaprazole, aceclofenac Cmax,ss
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
Maximum concentration of drug in plasma at steady state
ilaprazole, aceclofenac AUCtau,ss
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
Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state

5 secondary outcomes

ilaprazole, aceclofenac Tmax,ss
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
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
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
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
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

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Minsoo Park, PhD principal investigator

Severance Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ilaprazole and Aceclofenac in people with Drug Interaction Potentiation, run by Il-Yang Pharm. Co., Ltd. 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 9 inclusion and 25 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 28 Jun 2023. 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?

ilaprazole, aceclofenac Cmax,ss (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). The study lists 2 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 NCT05558150.

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 28 Jun 2023.