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임상시험 NCT07277712은(는) 건강 자원봉사자에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers 1상 74
\[Part A\] To evaluate and compare the pharmacokinetic and safety of co-administration of tegoprazan and naproxen versus administration of IN-M00002 tablet in healthy adult volunteers
\[Part B\] To evaluate the effects of food on the pharmacokinetic and safety of IN-M00002 tablet in healthy adult volunteers
A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers
- IN_TNA_101
food-effect
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Part A: Sequence 1 (Treatment A - Treatment B) Period 1: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID Period 2: Single dose of IN-M00002 tablet BID | Tegoprazan Tegoprazan 25 mg QD Naproxen Naproxen 500 mg BID IN-M00002 IN-M00002 tablet BID |
실험적Part A: Sequence 2 (Treatment B - Treatment A) Period 1: Single dose of IN-M00002 tablet BID Period 2: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID | Tegoprazan Tegoprazan 25 mg QD Naproxen Naproxen 500 mg BID IN-M00002 IN-M00002 tablet BID |
실험적Part B: Sequence 1 (Treatment C - Treatment D) Period 1: Single dose of IN-M00002 tablet QD under fasted conditions Period 2: Single dose of IN-M00002 tablet QD under fed conditions | IN-M00002 IN-M00002 tablet QD |
실험적Part B: Sequence 2 (Treatment D - Treatment C) Period 1: Single dose of IN-M00002 tablet QD under fed conditions Period 2: Single dose of IN-M00002 tablet QD under fasted conditions | IN-M00002 IN-M00002 tablet QD |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
AUCt of tegoprazan | Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration | Up to 48 hours |
AUCt of naproxen | Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration | Up to 72 hours |
Cmax of tegoprazan | Maximum plasma concentration of tegoprazan | Up to 48 hours |
Cmax of naproxen | Maximum plasma concentration of naproxen | Up to 72 hours |
- Healthy adult aged ≥ 19 and ≤ 55 year-old at screening
- Body mass index (BMI) ≥ 19.0 kg/m2 and ≤ 27.0 kg/m2 with a body weight ≥ 45 kg at screening
- Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines
- Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening
- Those with a capability/willingness to participate throughout the study
Medical history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, oncological, or immune disease (except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth)
Previous history of gastrointestinal disease (esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (except for simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption
Sitting systolic blood pressure < 90 mmHg or ≥ 140 mmHg or diastolic blood pressure < 60 mmHg or ≥ 90 mmHg at screening
Following findings of clinical laboratory tests:
- ALT or AST value > twice the upper limit of normal (ULN)
History of periodic alcohol consumption exceeding 210 g/week within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g)
Has taken any other investigational product within 6 months prior to the first dose of investigational product
History of serious alcohol or drug misuse and abuse within 1 year prior to screening
Administration of drugs known to markedly induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose of the investigational product
Daily use of ≥ 20 cigarettes within 6 months prior to screening
Administration of a prescription or non-prescription drug within 10 days prior to the first dose of the investigational product
Whole blood donation within 2 months prior to the first dose of the investigational product or apheresis donation within 1 month prior to the first dose of the investigational product
Subjects who received a blood transfusion within 1 month prior to the first dose of the investigational product
Those who may be put at an increased risk due to the administration of the investigational product and study participation or have a severe acute/chronic medical or mental condition which may interfere with the interpretation of study results
Subjects with a history of hypersensitivity (e.g., asthma, rhinitis, nasal polyps, urticaria, or allergic reactions) to the components of tegoprazan or naproxen, benzimidazole derivatives, aspirin, or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)
Subjects currently receiving medications containing atazanavir, nelfinavir, or rilpivirine
Women with a positive pregnancy test, pregnant, or breastfeeding
Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))
Subjects unable to consume a high-fat diet provided during Part B of the clinical trial
Subjects who are considered ineligible to participate in this study at the discretion of the investigator
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