To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.
* Arm A: To evaluate the effect of ATB-1012 on the safety and pharmacokinetic properties of ATB-1011 in steady state. * Arm B: To evaluate the effect of ATB-1011 on the safety and pharmacokinetic properties of ATB-1012 in steady state.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
ATB-1011 AUCτ,ss
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Time frame: 5days, 10days
ATB-1012 AUCτ,ss,
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Time frame: 5days, 10days
ATB-1011 Cmax,ss
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Time frame: 5days, 10days
ATB-1012 Cmax,ss
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Time frame: 5days, 10days
ATB-1011 Tmax,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
Time frame: 5days, 10days
ATB-1011 Cmin,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
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Time frame: 5days, 10days
ATB-1012 Tmax,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
Time frame: 5days, 10days
ATB-1012 Cmin,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
Time frame: 5days, 10days