This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration of D565 and D930, in healthy male subjects
To healthy male subjects of thirty-two (32), Investigational products are administered following treatments in each period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Seoul National University College of Medicine and Hospital
Seoul, South Korea
AUCtau,ss of D565(Sequence1)
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
Time frame: 1day 0hour ~ 99day 0hour
AUCtau,ss of D930(Sequence1)
Area under the D930 concentration in blood-time curve from 0 to τ at steady
Time frame: 8day 0hour ~ 99day 0hour
AUCtau,ss of D565(Sequence2)
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
Time frame: 96day 0hour ~ 99day 0hour
AUCtau,ss of D930(Sequence2)
Area under the D930 concentration in blood-time curve from 0 to τ at steady
Time frame: 1day 0hour ~ 99day 0hour
Cmax,ss of D565(Sequence1)
The maximum D565 concentration between 0 and τ at steady state
Time frame: 1day 0hour ~ 99day 0hour
Cmax,ss of D930(Sequence1)
The maximum D930 concentration between 0 and τ at steady state
Time frame: 8day 0hour ~ 99day 0hour
Cmax,ss of D565(Sequence2)
The maximum D565 concentration between 0 and τ at steady state
Time frame: 96day 0hour ~ 99day 0hour
Cmax,ss of D930(Sequence2)
The maximum D930 concentration between 0 and τ at steady state
Time frame: 1day 0hour ~ 99day 0hour
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