KCT0009335已完成Unknown
An open-label, randomized, single-dose, 2-sequence, 2-period, crossover phase 1 study to evaluate the food effect on the safety and pharmacokinetics of AD-109” in healthy volunteers
Addpharma0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) A person who is 19 years of age or older at the time of a screening visit
- •2) Those who weigh 50 kg or more (women weigh 45 kg or more) and have a BMI of 18.0 kg/m2 or more and 30.0 kg/m2 or less at screening visits
- •? BMI (kg/m2) = Weight (kg)/{Height (m)}2
- •3) A person who has no birth or chronic disease based on screening and has no medical examination results or no pathological symptoms or findings
- •4) A person who is deemed suitable as a test subject as a result of clinical laboratory tests (hematology tests, blood coagulation tests, blood chemistry tests, serological tests, urine tests etc.) and electrocardiogram tests (EKG) established and conducted by a person in charge of testing (or a delegated doctor in charge of testing) according to the characteristics of clinical trials
- •5) A person who has agreed to exclude the possibility of pregnancy using medically appropriate contraception* and not to provide sperm or ovum by himself/herself, his/her spouse, or his/her partner from the date of first administration of the clinical trial drug until 7 days after the date of last administration of the clinical trial drug
- •* Contraception: Use a combination of intrauterine devices, vasectomy, ovarian ligation and blocking contraception (male condoms, female condoms, cervical caps, contraceptive septum, sponges, etc.) or more than one blocking contraception when using a fertilizer
- •6) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of clinical trial drugs, and expected adverse reactions, etc. of this clinical trial
排除标准
- •1) Those who have or have a history of clinically significant diseases corresponding to digestive systems, cardiovascular systems, endocrine systems, respiratory systems, blood and tumors, infectious diseases, kidney and urinary systems, mental and nervous systems, musculoskeletal systems, immune systems, otolaryngological systems, dermatological systems, and ophthalmology
- •2) A person who has a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or who has gastrointestinal diseases
- •3) A person who has taken a drug metabolite-inducing and inhibiting drug such as barbiturant drugs within one month of the first administration date or who has taken a drug that may interfere with this clinical trial within 10 days of the first administration (but can participate in consideration of pharmacokinetics and pharmacodynamics such as interaction with clinical trial drugs and half-life of concomitant drugs)
- •4) A person who has participated in other clinical trials or biological equivalence trials within six months of the first administration and administered clinical trials
- •5) A person who has donated whole blood within 8 weeks of the first administration date or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks
- •6) A person who falls under the following conditions within one month of the first administration date
- •· For men, the average alcohol consumption exceeds 21 cups/week
- •· For women, the average alcohol consumption exceeds 14 cups/week
- •(1 glass = 50 mL of soju or 30 mL of spirits or 250 mL of beer)
- •· an average of more than 20 cigarettes a day
- •7) any of the following persons
- •· Patients with a history of hypersensitivity to the main or other components of this drug
- •· Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •· Combination therapy of other anticoagulants: When combined with other anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparin, etc.), or oral anticoagulants (warfarin, apixaban, dabigatran, etc.)
- •· Those who use antiplatelet drugs in combination in patients with a history of stroke or transient ischemic attacks in the treatment of acute coronary syndrome
- •8) a patient with the following conditions
- •· Patients with clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
- •· Patients with liver disease associated with hemicoagulant disorder and those with liver disease associated with clinically significant risk of bleeding such as Child Pugh B and C
- •· a patient at increased risk of bleeding due to an illness
- •- a recent history of gastrointestinal ulcers
- •- Recent history of intracranial or intracranial hemorrhage
- •- Intra-spinal or intracerebral vascular abnormalities
- •- Recent history of brain, spinal cord or ophthalmic surgery
- •- recent brain or spinal cord injury
- •- If you have or suspect esophageal varicose veins
- •- arteriovenous malformations
- •- Vascular aneurysms
- •- a patient with a malignant tumor (neoplasm) at high risk of bleeding
- •9) A person who determines that the person in charge of the test (or the delegated person in charge of the test) is not suitable for participation in this clinical trial due to reasons other than the above criteria for selection and exclusion
- •10) In the case of female volunteers, a p
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