A Phase 1 interventional study of CKD-381 and Nexium in GERD, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment
A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects
A randomized, open-label, multiple-dose, and crossover study to compare pharmacokinetics, pharmacodynamics and safety of CKD-381 and D027 in healthy subjects
Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
If female, must include more than one among the items
Exclusion Criteria:
Defined by the following laboratory parameters
TR group Period 1: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days Period 2: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days
Drug: CKD-381 · Drug: Nexium
RT group Period 1: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days Period 2: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days
Drug: CKD-381 · Drug: Nexium
Test drug: CKD-381
Also known as: Esomeprazole 20mg+Sodum bicarbonate 800mg
Reference drug: Nexium
Also known as: Esomeprazole magnesium trihydrate 22.3mg
Pharmacokinetics(Area under the plasma drug concentration-time curve within a dosing interval(AUCτ))
Evaluating PK of Esomeprazole after Multiple dose
Time frame: 0h~12 h
Pharmacodynamics(Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose)
Evaluating PD for ambulatory 24hr pH monitor
Time frame: Baseline versus Multiple dose during 7days
Plan to share: No
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Chong Kun Dang Pharmaceutical