KCT0000435招募中未知
A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g co-administration and HCP1007 in Healthy Male Volunteers
Hanmi Pharm0 个研究点目标入组 28 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 28
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
- 20(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy men aged 20 to 45, inclusive, at screening.
- •2. 20 kg/m2 = Body mass index (BMI) = 26 kg/m2 at screening.
- •3. Sitting blood pressure meeting the following criteria at screening:
- •90 = systolic blood pressure < 140 (mmHg) and
- •60 = diastolic blood pressure < 100 (mmHg)
- •4. Volunteers, who can sufficiently understand and comply with these instructions and who, prior to participation in the study, voluntarily give written informed consent to willingly participating in the study throughout the study period after receiving sufficient information about the purpose and content of this study as well as characteristics of the study drug.
- •5. Volunteers from whom blood sampling is available during the study period.
排除标准
- •1.Present or past diseases of clinical significance in liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrines, neuropsychiatric system, blood and tumor, or cardiovascular system.
- •2. A history of gastrointestinal diseases (e.g. Crohn’s disease, ulcer, etc.) or surgical operations (except for simple appendectomy or hernia repair) that may affect absorptions of the investigational product.
- •3. A history of clinically significant hypersensitivity reactions including hypersensitivity reactions to Omega-3, Rosuvastatin, or drugs that contain components of the same class, or other drugs (aspirin, antibiotics, etc.) and hypersensitivity reactions to fish.
- •4. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential (e.g., amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, THC (cannabinoids), methadone, etc.) in urine screenings for drugs.
- •5. Administration of ethical drugs or herbal medicine within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- •6. Administration of other investigational products within 60 days prior to the first dosing.
- •7. Whole blood donation within 60 days, apheresis donation within 30 days, or receipt of blood transfusion within 30 days prior to the first dosing.
- •8. Administration of drug metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
- •9. Volunteers who have been maintaining abnormal diets that may affect absorption, distribution, metabolism, and excretion of drugs within 30 days prior to the first dosing.
- •10. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
研究者
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