KCT0007131已完成未知
An open-label, randomized, crossover phase 1 clinical trial to evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of ABN401 in healthy adult volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Healthy subjects aged over 19 years (inclusive) at the time of screening
- •2)Subjects weighing at least 50.0 kg with a BMI between 18.0 kg/m2 and 30.0 kg/m2 (inclusive)
- •? BMI (body mass index) = {weight (kg) / height (m)2}
- •3)Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination
- •4)Subjects considered eligible for the study participation in accordance to the results of vital signs, 12-lead ECG, clinical laboratory tests (including hematology, blood chemistry, urinalysis, serology, etc.) and urine drug screening conducted at the time of screening, based on the investigational product (IP) characteristics (In cases of the results outside the NCS range considered due to irregular lifestyle (drinking, night-time shifts, etc.) final decision of inclusion can be made with additional follow-up after modification of the causal lifestyle)
- •5)Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period
排除标准
- •1)Subjects with any clinically significant hepatic, renal, nervous, psychiatric, respiratory, endocrine, circulatory system, neoplastic, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases, or a past medical history of any of the aforementioned conditions.
- •2)Subjects with a past medical history of gastrointestinal disease (Crohn’s disease, ulcers, acute/chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy and hernia repair) which may affect the absorption of the IP.
- •3)Subjects with clinically significant 12-lead ECG findings including the following results at the time of screening.
- •?QTc > 450 ms
- •?PR interval > 200 ms
- •?QRS duration > 120 ms
- •4)Subjects with SBP = 150 mmHg or = 90 mmHg; DBP = 100 mmHg or = 60 mmHg; PR = 40 beat/min or = 100 beat/min, when measured in a seated position without an abrupt change in body position for at least 3 minutes.
- •5)Subjects with laboratory test results as follows.
- •?Liver function test (AST, ALT, ALP, ?-GTP and total bilirubin) values exceeding twice the upper limit of normal.
- •?Creatinine values outside the reference ranges or eGFR < 60 mL/min/1.73m2
- •6)Subjects who have participated and given any other study drugs in other clinical study or bioequivalence study within 6 months prior to the first IP administration (the last day of IP administration is considered the end-of-study).
- •7)Subjects with a past history of drug abuse or a positive urine drug screening test.
- •8)Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals, within 1 month prior to the first IP administration.
- •9)Subjects who have taken any prescribed medications or herbal medicine within 2 weeks or any over-the-counter medications or vitamin supplements within 10 days prior to the first IP administration (except for circumstances considered acceptable with no concerned effect on the pharmacokinetics of the IP at the investigator’s discretion).
- •10)Subjects with hypersensitivity reactions or a clinically significant medical history of hypersensitivity reactions to drug substances and additives or other drugs (such as aspirin, anti-biotics, biguanides, etc.).
- •11)Subjects who have donated whole blood within 2 months or blood components within 1 month or received a blood transfusion within 1 month prior to the first IP administration.
- •12)Subjects who have consistently drunk alcohol within 6 months exceeding 21 units/week (1 unit= 10 g) prior to the first IP administration or are unable to refrain from drinking from the time of consent until PSV.
- •*Alcohol consumption (g) = amount (mL) x alcohol by volume (%) x 0.8* (*pure alcohol 10 g = 12.5 mL)
- •13)Subjects who have smoked more than 10 cigarettes/day on average 3 months prior to the first IP administration and are unable to oblige the no-smoking rules from 24 hours prior to the first IP administration until the last blood sampling point.
- •14)Subjects unable to refrain from consuming grapefruit-containing food or beverages from 48 hours prior to the first IP administration until PSV.
- •15)Subjects unable to refrain from consuming caffeine-containing food or beverages (coffee, green tea, black tea, carbonated drinks, coffee-flavored milk, energy drinks, etc.) from 24 hours prior to the first IP administration until the last blood sampling point.
- •16)Subjects unable to refrain from vigorous exercise which exceeds daily routine from 48 hours prior to
研究者
相似试验
已完成
不适用
An open-label, randomized, crossover, phase 1 study to evaluate bioequivalence and relative bioavailability between JZP-507 commercial scale and pilot oral solutions in healthy subjectsnarcolepsysleeping disorder10040998NL-OMON44398Jazz Pharmaceuticals, inc.30
未知
1 期
A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg TabletsJPRN-jRCT2080222761TAKEDA PHARMACEUTICAL COMPANY LTD.24
已完成
不适用
A phase I, open-label, randomized crossover trial in 24 healthy subjects to investigate the effect of steady-state esomeprazole on the pharmacokinetics of a single dose of telaprevir.contagius jaundiceviral leverinflammation10047438NL-OMON31863Janssen-Cilag24
进行中（未招募）
1 期
A study to assess the food effect and how fast JNJ-53718678 reaches the blood stream of healthy adult subjects after being dosed with 250-mg as an oral solid concept compared with suspension; and the effect of storage conditions on how long the drug stays and acts in the body after administration of JNJ-53718678Respiratory Syncytial VirusMedDRA version: 20.0Level: HLTClassification code 10038717Term: Respiratory syncytial viral infectionsSystem Organ Class: 100000004862EUCTR2020-000369-18-BEJanssen Sciences Ireland Unlimited Company (UC)84
进行中（未招募）
1 期
A Study to Evaluate the Relative Bioavailability of Tezacaftor/Ivacaftor GranulesMedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2020-000689-40-Outside-EU/EEAVertex Pharmaceuticals Incorporated16