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临床试验/2023-504760-42-00
2023-504760-42-00已完成4 期

An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.

Dermax1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月20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
30
试验地点
1

研究概览

简要总结

暂无简介。

入排标准

年龄范围
18 years 至 64 years(18-64 Years)
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
Dermax
申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

Christophe Lyssens

Scientific

Dermax

研究点 (1)

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An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.ot applicable (submitted trial is a bioequivalence study in healthy subjects)MedDRA version: 20.0Level: HLGTClassification code: 10047438Term: Viral infectious disorders Class: 10021881
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