An open-label, randomised, single dose, two-way crossover pilot study to determine the relative bioavailability of one 16 mg tablet formulation of candesartan cilexetil (GW615775) relative to one 16 mg reference tablet of candesartan cilexetil (Atacand) in healthy adult human subjects under fasting conditions

GlaxoSmithKline Research and Development Limited0 个研究点目标入组 16 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent
•Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria,outside the reference range for the population being studied may be included only if
•the Investigator in consultation with the GSK Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
•Body weight >= 50kg and BMI within the range 19 â?? 24.9kg/m2 (inclusive)
•Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods This criterion must be followed from the time of the first dose of study medication until the follow-up contact visit
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
•ALT, alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
•Based on single or averaged QTc of triplicate ECGs obtained over a brief recording period: QTcF < 450 msec

•Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug
•Any subject with a systolic BP <95mmHg or with a recent history of postural symptoms

发起方

GlaxoSmithKline Research and Development Limited