An open-label, randomised, single dose, three-way crossover, six sequence, pilot study to determine the relative bioavailability of mosapride 5mg from two candidate formulations of GR107719B relative to one 5mg tablet of reference mosapride citrate (Gasmotin) in healthy adult human subjects under fasting conditions

GlaxoSmithKline Research and Development Limited0 个研究点目标入组 18 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 >= 50 kg and BMI within the range 19 â?? 24.9 kg/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 values 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
•The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)

发起方

GlaxoSmithKline Research and Development Limited