Kyungpook national university hospital
Daegu, South Korea
NCT Number: NCT03985319
Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)
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Notify Me19 year and older
All sexes
Interventional
Phase 1
Daegu, South Korea
To evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 20mg and Nexium tab 20mg and the effects of food influence the PK/PD of YYD601 20mg in a healthy adults.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)
Other names: Experimental drug
Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori
Other names: comparator drug
Time frame: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
Cmax after single administration and repeated administration
Time frame: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
AUC after single administration and repeated administration
Time frame: pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day
AUC after single administration and repeated administration
Time frame: pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day
Tmax after single administration and repeated administration
Time frame: pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day
t1/2 after single administration and repeated administration
Yooyoung Pharmaceutical Co., Ltd.
Industry
A Randomized, Open-label, Cross-over Design Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Properties and Safety of YYD601 20mg After Oral Administration in Healthy Adult Subjects (Phase1)
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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