CHA Bundang Medical Center, CHA University
Bundang, Gyeonggi-do, 13496, South Korea
NCT Number: NCT04150146
This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.
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Notify Me19 year–45 year
Male
Interventional
Phase 1
Bundang, Gyeonggi-do, 13496, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Test Drug
Reference Drug
Time frame: From Period1/ Day1 to Period2/Day9
Peak Plasma Concentration of Rebamipide
Time frame: From Period1/ Day1 to Period2/Day9
Area Under the plasma concentration versus time curve last of Rebamipide
Time frame: From Period1/ Day1 to Period2/Day9
Time taken for half the initial dose of Rebamipide administered to be eliminated from the body
Time frame: From Period1/ Day1 to Period2/Day9
Time at which the Cmax of Rebamipide is observed
Time frame: From Period1/ Day1 to Period2/Day9
Area Under the plasma concentration versus time curve inifinite of Rebamipide
Korea Otsuka Pharmaceutical Co., Ltd.
Industry
A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of "Rebamipide Sustained Release (SR) 150mg" in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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