2022-503083-32-00已完成4 期
Randomised bioequivalence clinical trial of sacubitril/valsartan 97 mg/103 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.
Laboratorios Normon S.A.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年3月7日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Sacubitril AUC0-t
研究概览
简要总结
To evaluate the relative bioavailability of the test formulation of sacubitril/valsartan tablets compared to the commercial formulations taken as reference and to demonstrate their bioequivalence according to health authorities’ criteria.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects who, after receiving information about the design, the objectives of the project, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written consent to participate in the study.
- •Aged from 18 to
- •No clinically significant organic or psychic conditions.
- •No clinically significant abnormalities in medical records and physical examination.
- •No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis (see Appendix B).
- •No clinically significant abnormalities in vital signs and electrocardiogram.
排除标准
- •Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].
- •Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
- •Inability to follow the instructions or collaborate during the study.
- •History of difficulty in swallowing.
- •Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.
- •Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
- •History of sensitivity to any drug.
- •Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
- •Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
- •Having donated blood in the last month before start of the study.
- •Pregnant or breastfeeding women. Child-bearing age women participating in the study will compromise to use a high effective contraceptive method (see Appendix C) or will be abstinent during their participation in the study.
结局指标
主要结局
Sacubitril AUC0-t
Sacubitril AUC0-t
Sacubitril Cmax
Sacubitril Cmax
Valsartan AUC0-t
Valsartan AUC0-t
Valsartan Cmax
Valsartan Cmax
次要结局
- Sacubitril AUC0-∞
- Sacubitril Tmax
- Sacubitril residual area
- Valsartan AUC0-∞
- Valsartan Tmax
- Valsartan residual area
研究者
Carlos Govantes (R&D Director)
Scientific
Laboratorios Normon S.A.
研究点 (1)
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