KCT0000821已完成未知
A randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, crossover study to evaluate the safety and pharmacokinetics of FOM-D31 and desmopressin tablet in healthy volunteers
Kuhnil Pharm0 个研究点目标入组 62 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 62
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 55(Year)（—）
- 性别
- All
入选标准
- •1. Healthy adults between the ages of 20 and 55 years
- •2. Body weight more than 55 kg, and within 20% of ideal body weight (IBW)
- •IBW (kg)=[height(cm)-100]?0.9
- •3. Have not any congenital or chronic disease and medical symptoms
- •4. No clinically relevant abnormalities identified by laboratory test, including Hematology, Blood chemistry, Urinalysis
- •5. Agreement with written informed consent
排除标准
- •1. Subjects who has clinically relevant current disease or history of liver-biliary teact, kidney, central (peripheral) nervous system, cardiovascular system, blood tumor, urinary system, mental disease, musculoskeletal system, immune system, otorhinolaryngologic system, endocrine system
- •2. Subjects who has a history of gastrointestinal disease that may affect the bioavailability of the study preparation
- •3. Subjects who are hypersensitive to desmopressin or other related compounds.
- •4. SBP =130 mmHg or = 85 mmHg, DBP = 90 mmHg or = 60 mmHg in the sitting position after a 3 minute rest
- •5. Serum sodium level <133 mEq/L
- •6. Creatinin clearance < 50 mL/min according to Cockcroft-Gault equation
- •7. Using diuretics
- •8. History of drug abuse or currently using an abusable medicine
- •9. Received OTC drugs or vitamins within a week, or ETC drugs or oriental medicine within 2 weeks before the first IP administration
- •10. Previously any IP administration in other trial within 60 days
- •11. Previously make whole blood donation within 2 months or component blood donation within a month or blood transfusion within a month before the first IP administration
- •12. Chronic alcohol consumption (21 units/week, 1 unit=10 g of pure alcohol) or disagreement to abstain from alcohol during study periods
- •13. Who have smoked >10 cigarettes per day for the past 3 months
- •14. Inappropriate subject for entry into this study in the judgement of the investigator
- •15. Pregnant or nursing female
研究者
相似试验
已完成
不适用
the safety and pharmacokinetics of tadalafil 20 mg tablet and tadalafil 20 mg Oral Dissolving Film in healthy male volunteersDiseases of The genitoruinary systemKCT0002360CLPharm40
尚未招募
1 期
A Single-dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Full Replicate Crossover Bioequivalence Study of Generic Edoxaban 60 mg Film-coated Tablets (Unison Laboratories Co., Ltd.) and Reference Product (Lixiana) in Healthy Thai Volunteers under Fasting ConditionsBioequivalence Study of Edoxaban 60 mg Film-coated Tablets in Healthy Thai Volunteers under Fasting ConditionsTCTR20230826003nison Laboratories Co., Ltd.30
已完成
不适用
Study to investigate the effect of atorvastatin on the pharmacokinetic properties of telmisartan/s-amlodipine after oral administration in healthy volunteersDiseases of the circulatory systemKCT0000811Chong Kun Dang24
已完成
不适用
Study to investigate the effect of telmisartan/s-amlodipine on the pharmacokinetic properties of atorvastatin after oral administration in healthy volunteersDiseases of the circulatory systemKCT0000810Chong Kun Dang24
已完成
不适用
Bioequivalence study of Fingolimod 0.5 mg capsulesCTRI/2012/05/002703MSN Laboratories Ltd32