跳至主要内容
临床试验/NL-OMON36253
NL-OMON36253已完成不适用

A double-blind, placebo controlled, randomized study to evaluate the safety, tolerability, pharmacokinetic profile and cytochrome P450 interaction potential of single and multiple doses of Tonabersat over the dose range of 240 mg to 480 mg in healthy adult subjects. - SAD/MAD/DDI study.

psher-Smith Laboratories, Inc.0 个研究点目标入组 129 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
129

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
18 至 99(—)

入选标准

  • 18 - 65 years, BMI 18 - 30 kg/m2, no smoker or a moderate smoker i.e. * 5 cigarettes per day.

排除标准

  • Suffering from: hepatitis A, B or C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

研究者

发起方
psher-Smith Laboratories, Inc.

相似试验

进行中(未招募)
不适用
A double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of TAK-475 or placebo when co-administered with current lipid-lowering therapy in subjects with homozygous familial hypercholesterolemiaTreatment of primary dyslipidemiaMedDRA version: 8Level: PTClassification code 10058108
EUCTR2005-003626-26-GBTakeda Europe R&D Centre Ltd40
进行中(未招募)
不适用
A placebo-controlled, double-blind, randomized study to evaluate the efficacy and safety of TAK-475 50mg and 100mg versus placebo, when co-administered with simvastatin 20mg or 40mg in subjects with primary dyslipidemia.Treatment of patients with primary dyslipidaemia currently taking simvastatin 20mg or 40mgMedDRA version: 8Level: PTClassification code 10058108
EUCTR2005-002313-21-DETakeda Europe R&D Centre Limited420
进行中(未招募)
1 期
A placebo-controlled, double-blind, randomized study to evaluate the efficacy and safety of TAK-475 50mg and 100mg versus placebo, when co-administered with simvastatin 20mg or 40mg in subjects with primary dyslipidemia.Treatment of patients with primary dyslipidaemia currently taking simvastatin 20mg or 40mgMedDRA version: 8Level: PTClassification code 10058108
EUCTR2005-002313-21-FITakeda Europe R&D Centre Limited
进行中(未招募)
1 期
A placebo-controlled, double-blind, randomized study to evaluate the efficacy and safety of TAK-475 50mg and 100mg versus placebo, when co-administered with simvastatin 20mg or 40mg in subjects with primary dyslipidemia.
EUCTR2005-002313-21-LVTakeda Europe R&D Centre Limited
进行中(未招募)
1 期
A placebo-controlled, double-blind, randomized study to evaluate the efficacy and safety of TAK-475 50mg and 100mg versus placebo, when co-administered with simvastatin 20mg or 40mg in subjects with primary dyslipidemia.Treatment of patients with primary dyslipidaemia currently taking simvastatin 20mg or 40mgMedDRA version: 8 Level: PT Classification code 10058108
EUCTR2005-002313-21-GBTakeda Europe Research & Development Limited
A double-blind, placebo controlled, randomized study... | 临床试验