KCT0008390进行中（未招募）Unknown
A randomized, open-label, multiple-dose, crossover study to compare the safety, pharmacokinetics and pharmacodynamics of DHNP-2001B to RD-02 in healthy adult subjects
DaehanNupharm0 个研究点目标入组 44 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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 55(Year)（—）
- 性别
- All
入选标准
- •1) Healthy adults aged 19 to 55 at the time of screening test
- •2) Those who weigh not less than 50.0 kg and not more than 90.0 kg and have a BMI of not less than 18.0 kg/m2 but not more than 28.0 kg/m2 at the time of screening test
- •? Body mass index (kg/m2) = Weight (kg)/[Height (m)]2
- •3) Those who were tested negative for serum Helicobacter pylori anibody
- •4) A person who has heard and fully understood this clinical trial and has voluntarily decided to participate and has agreed in writing to comply with the precautions
- •5) A person who is suitable as a test subject when judging a tester through physical examination, clinical laboratory examination, questionnaire, etc
排除标准
- •.1) A person who has or has a history of diseases corresponding to clinically significant hepatabiliary system, kidney, nervous system, immune system, respiratory system, digestive system, endocrine system, blood • tumor, cardiovascular system, urinary system, psychiatric disease, etc
- •2) A person who has a history of hypersensitivity to drugs and other drugs (aspirin, antibiotics, etc.) containing the same family, or of clinically significant hypersensitivity reactions
- •3) Gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation of clinical trial drugs (except simple appendectomy, hernia surgery)
- •4) A person who has shown the following results in a screening test
- •- Blood AST (SGOT), ALT (SGPT) > Normal Range Upper Limit × 1.5
- •- Serum test (Hepatitis B test, Hepatitis C test, Human Immunodeficiency Virus (HIV) test) results positive
- •5) Those who are unable to insert and maintain the pH monitor catheter due to anatomical problems
- •6) A person who has a history of drug abuse or has tested positive for an abused drug in a urine screening test
- •7) A person who has taken a specialized drug within two weeks prior to the first scheduled date of administration of a clinical trial drug, or has taken any general drug, health functional food, vitamin preparation or herbal medicine within one week, or is expected to be taken
- •8) A person who has taken a drug metabolite enzyme-induced and inhibitory drug, such as a barbiturate drug, within one month prior to the first scheduled administration of a drug for clinical trials
- •9) Participants in other clinical trials (including biological equivalence tests) within 6 months prior to the scheduled date of the first administration of the clinical trial drug
- •10) Blood transfusion within two months before the first administration of the clinical trial drug, or component blood donation within one month, or blood transfusion within one month before the first administration of the clinical trial drug
- •the recipient
- •11) Continuous drinking (above 21 units/week, 1 unit = 10 g of pure alcohol) or during the period from 3 days prior to the scheduled date of the first administration of the clinical trial drug to the last discharge
- •an irresistible person
- •12) A current smoker or a person who is unable to stop smoking for a period from three months prior to the scheduled first administration of clinical trial drugs to the last discharge
- •13) A person who is unable to consume grapefruit-containing food during the period from three days prior to the scheduled first administration of clinical trial drugs to the last discharge
- •14) A person who has a unique eating habit (e.g. intake of grapefruit-containing beverages per day, continuous vegetarian eating habits, etc.) or is unable to eat the meals provided in this clinical trial
- •15) Caffeine/caffeine-containing foods (coffee, tea, soda, etc.) for a period from 3 days prior to the expected first administration date to the last discharge,
- •A person who is unable to prohibit the consumption of coffee milk, energy tonic drinks, etc.)
- •16) Appropriate double contraception or medically recognized by you, your spouse or partner during the pre-clinical trial period and at least four weeks after the administration of the last clinical trial drug
- •A person who is unable to use acceptable contraception and who does not agree to donate sperm
研究者
相似试验
已完成
不适用
A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Rosuvastatin and Telmisartan in Healthy VolunteersKCT0000584Yuhan48
已完成
Unknown
Targeting healthy adult volunteers. The subjects are assigned to sequence 1 or sequence 2 through randomization. Once assigned to the sequence, repeated oral administration of the Test IP(DHNP-2001A) and the Reference IP(RD-01) in that order. The test is divided into Period 1 and 2, and in the case of Period 2 administration, the opposite of Period 1 administration is administered. This clinical trial is designed open-label and aims to compare pharmacokinetic and pharmacokinetic characteristics and safety.KCT0008519DaehanNupharm44
进行中（未招募）
不适用
Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR capsule 32 mg and Dilatrend® tablet 25 mgKCT0000787Chong Kun Dang48
已完成
不适用
A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Linagliptin after oral administration in healthy male volunteerEndocrine, nutritional and metabolic diseaseKCT0001326Dong Hwa Pharm12
已完成
不适用
A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteerEndocrine, nutritional and metabolic diseaseKCT0001386Dong Hwa Pharm12