Dong-A University Hospital
Seo-gu, Busan, 602-715, South Korea
NCT Number: NCT03034486
This study is a single sequence, 3-period, multiple-dose study to evaluate the pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of D930 in healthy male volunteers.
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Notify Me19 year–55 year
Male
Interventional
Phase 1
Seo-gu, Busan, 602-715, South Korea
This study is a single sequence, 3-period, multiple-dose study to evaluate the pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of D930 in healthy male volunteers.
Subjects will receive D565 just one time on period 1 for evaluate the pharmacokinetics. And afterward, subjects will receive multiple dose of D930 for 9 days, and D565 with D930 for 9 days to evaluate the drug effect on period 2 and 3.
When period 1 finished, there are 3 days of washout period, but between period 2 and 3, there is no washout period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Period 1: D565 administered 1 time for one day/ Period 2: D930 administered 3 time per day for 9 days/ Period 3: D565(1 time per day) with D930(3 time per day) administered for 9days
Time frame: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Time frame: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Time frame: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Time frame: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Time frame: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Time frame: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Time frame: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Time frame: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Time frame: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Time frame: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Time frame: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Chong Kun Dang Pharmaceutical
Industry
A Single Sequence, 3-period, Multiple-dose Study to Evaluate the Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930 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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