Chonbuk National University Hospital
Jeonju, South Korea
NCT Number: NCT03569579
The purpose of this study is to evaluate a pharmacokinetic drug interaction between D797 of D324 in healthy volunteers
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Notify Me19 year and older
All sexes
Interventional
Phase 1
Jeonju, South Korea
To healthy subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 21 days.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a. ALT or AST > twice higher than normal value
Who has a serious heart failure or a congestive heart failure that must be drug-treated
Memantine Tab. 10mg* 2T/day, QD, PO
Other names: Ebixa Tab. 10mg
Memantine Tab. 10mg* 2T/day + Donepezil Tab. 10mg * 1T/day, QD, PO
Other names: Ebixa Tab. 10mg + Aricept Tab. 10mg
Time frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Area under the plasma concentration of Memantine versus time curve from time zero to time of last quantifiable concentration
Time frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Maximum plasma concentration of Memantine
Time frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Area under the plasma concentration of Memantine versus time curve from time zero to time infinity
Time frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Time to maximum concentration of of Memantine
Time frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Apparent terminal half-life of Memantine
Time frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Total body clearance of Memantine
Time frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Apparent volume of distribution of Memantine
Chong Kun Dang Pharmaceutical
Industry
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Effect of D797 on Pharmacokinetics of D324 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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