Asan Medcial Center
Songpa-gu, Seoul, 138-736, South Korea
NCT Number: NCT01369472
This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.
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Notify Me20 year–54 year
Male
Interventional
Phase 1
Songpa-gu, Seoul, 138-736, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single oral administration in period 1 or 2, 3 for each sequential group.
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
AUClast
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
AUC0-∞
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Cmax
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Tmax
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
t½β
Time frame: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)
Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests
Chong Kun Dang Pharmaceutical
Industry
A Randomized, Open-label, Single Dose, Dose-rising 10-sequence, 3-period Balanced Incomplete Blocked Clinical Trial to Evaluate Dose-proportionality of Dilatrend SR in Healthy Male 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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