Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T
NCT ID: NCT05617651
Last Updated: 2023-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2024-11-30
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A group
Period 1 : Ilaprazole 10mg 2Tab, one a day
Period 2 : Ilaprazole 20mg 1Tab, one a day
Period 3 : Ilaprazole 10mg 2Tab, one a day
IY-NT-T
Ilaprazole 20mg
IY-NT-R
Ilaprazole 10mg
B group
Period 1 : Ilaprazole 20mg 1Tab, one a day
Period 2 : Ilaprazole 10mg 2Tab, one a day
Period 3 : Ilaprazole 20mg 1Tab, one a day
IY-NT-T
Ilaprazole 20mg
IY-NT-R
Ilaprazole 10mg
Interventions
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IY-NT-T
Ilaprazole 20mg
IY-NT-R
Ilaprazole 10mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A volunteer who weighs ≥ 50kg (≥ 45kg for women) and has a body mass index(BMI)\* of ≥18.0 and ≤ 30 at screening
\*BMI(body mass index, kg/m\^2)= Body weight (kg)/\[height (m)\^2\]
3. A volunteer who has no congenital or chronic diseases, no pathological symptoms, or findings from medical examination at screening
4. A volunteer who is determined by the principal investigator or sub-investigator(responsible physician) as eligible as a subject based on diagnostic tests( hematology, hematochemical, serum, urinalysis) and electrocardiogram tests established and conducted according to the characteristics of the study drug
5. A volunteer and their spouse or partner, who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of study drug
\* Contraception methods: Intrauterine device, vasectomy, tubal ligation and contraceptive barrier methods (male condoms, women condoms, cervical caps. Contraceptive diaphragm, sponge,etc) used in combination or if spermicide is used, two or more contraceptive barrier methods
6. A volunteer who voluntarily provided written consent to participation in the entire study process after being fully informed of the study objective, contents, characteristics of the study drugs, and expected adverse reactions, prior to study participation
Exclusion Criteria
2. A volunteer who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
3. A volunteer who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first dose or who has taken drugs that may interfere with clinical study within 10 days prior to the first dose(Provided that, participation may be considered based on drug-drug interaction, pharmacokinetics and pharmacodynamics(such as half-life) of study drug)
4. A volunteer who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the study drug
5. A volunteer who has participated in whole blood donation within 8 weeks prior to first dose, or apheresis donation within w weeks prior to first dose, or received blood donation within 4 weeks prior to first dose.
6. A volunteer that meets any of the following conditions within 1 month prior to first dose
* Average alcohol intake(for men): \> 21 glass/week
* Average alcohol intake(for women): \> 14 glass/week (1 glass = 50ml of soju or 30ml of liquor, or 250ml of beer)
* Average cigarette smoking: \> 20 cigarettes per day.
7. A volunteer that meets any of the following categories
* Volunteer who is hypersensitive to the active ingredient or other ingredients of this drug
8. Patients that meet any of the following conditions
* Gastric ulcer patients possibly related to a malignant tumor
* Hepatic disorder or renal disorder patients
* Patients receiving Atazanavir
* Patients receiving Rilpivirine-containing products
9. A volunteer who is considered by the investigator to be ineligible to participate in this study for other reasons
10. Pregnant or nursing women
19 Years
ALL
Yes
Sponsors
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Il-Yang Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jae Woo Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
H Plus Yangji Hospital
Locations
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H plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DTC22-IP018
Identifier Type: -
Identifier Source: org_study_id
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