KCT0009354已完成Unknown
An open label, randomized, single oral dose, 2-sequence, 4-period, cross-over phase 1 study under fasting state to evaluate the pharmacokinetic characteristics and safety/tolerability of coadministration (AD-2071 and AD-2072) or fixed-dose combination(AD-207) in healthy adult volunteers
Addpharma0 个研究点目标入组 56 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 56
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) A person who has no birth or chronic disease based on screening and has no medical examination results (e.g., electrocardiogram, chest and gastroscopy or gastrointestinal radiography if necessary) or no pathological symptoms or findings
- •3) A person who is deemed suitable as a test subject as a result of clinical laboratory tests (hematology tests, blood chemistry 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
- •4) those with the following blood pressure
- •·Systolic blood pressure not less than 90 mmHg but not more than 139 mmHg
- •·The diastolic blood pressure is greater than or equal to 60 mmHg and less than or equal to 89 mmHg
- •5) A person whose BMI measurement results are greater than or equal to 18kg/m2 and less than or equal to 30kg/m2 at the time of a screening visit
- •·BMI (kg/m2) = Weight (kg) / Height (m) 2
- •6) Those who have no history of gastrointestinal diseases or gastrointestinal resection that can affect the absorption of clinical trial drugs
- •7) A person who has no history of mental illness within five years prior to the date of the screening visit
- •8) In the case of a female test subject, a person who is confirmed not to be pregnant at the time of a medical examination
- •9) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of the drug, expected adverse reactions, etc. of this test
排除标准
- •1) A person who has taken drug metabolite-inducing and inhibiting drugs such as barbiturant drugs within 30 days prior to the date of the screening visit
- •2) Drug users who are likely to interfere with testing within 10 days prior to a screening visit
- •3) Excessive alcohol drinkers within 30 days prior to the date of the screening visit
- •·More than 14 cups/week for women
- •·More than 21 cups/week for men
- •(1 glass = 50mL of soju or 30mL of spirits or 250mL of beer)
- •4) Excessive smokers within 30 days prior to the date of the screening visit (over 20 cigarettes/day)
- •5) A person who has participated in other clinical trials or biological equivalence trials within six months prior to the first dose of a clinical trial drug
- •6) A person who has donated whole blood or donated ingredients within 14 days or received a blood transfusion within 30 days before the first dose of clinical trial drugs
- •7) A person who has a history of hypersensitivity to the main component (or dihydropyridine-based derivative) or components of clinical trial drugs or other drugs or additives, etc
- •8) A person who is not qualified for participation in this clinical trial by a person in charge of the trial (or a delegated test doctor)
- •9) Those whose blood AST (GOT) or ALT (GPT) levels exceed twice the upper limit of the reference range or whose ?-GTP levels exceed 1.5 times the upper limit of the reference range
- •10) A nursing mother
- •11) A patient with severe liver disorder or a person with biliary obstructive disease
- •12) a patient with severe aortic stenosis
- •13) Shock patient
- •14) People with muscle disease
- •15) Patients administered in combination with cyclosporine
- •16) Patients with renal impairment with moderate to severe renal failure
- •17) Patients prone to myopathy/rhabdomyolysis
- •18) Those with hypothyroidism
- •19) Those whose blood TSH level exceeds 5.50 µIU/mL
- •20) A person who has a history of genetic muscle disease or a family history
- •21) Those with a history of muscle toxicity to other HMG-CoA converting enzyme inhibitors or fibrate-based drugs
- •22) A person who is an alcoholic
- •23) A person on combination administration of fibrate-based drugs
- •24) Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption because this drug contains lactose
- •25) This drug contains sorbitol and therefore is genetically fructose intolerant
- •26) A person who does not agree to medically exclude the possibility of pregnancy by using contraception* by himself, his/her spouse, or his/her partner from the date of first administration of the clinical trial drug until 21 days after the date of last administration of the clinical trial drug
- •* Contraception: Use a combination of intrauterine devices (IUD, IUS), vasectomy, oviduct ligation and blocking contraception (male condom, female condom, cervical cap, contraceptive septum, sponge, etc.), or use a combination of two or more blocking contraception when using a fertilizer
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