This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects.
This study is to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects. Thirty subjects will be participating in a fasted state and other thirty subjects will be in a fed state. Elantan SR 60 mg and Imdur 60 mg are two formulations of Isosorbide 5-mononitrate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
* Trade Name: Elantan * Active Substance: Isosorbide 5-mononitrate * Pharmaceutical form: Tablet * Concentration: 60 mg * Route of Administration: Oral administration
* Trade Name: Elantan * Active Substance: Isosorbide 5-mononitrate * Pharmaceutical form: Tablet * Concentration: 60 mg * Route of Administration: Oral administration
1
Jeollabuk-do, South Korea
Area Under the Concentration-time Curve vs. time curve observed from time Baseline to the Last Quantifiable point (AUC(0-t))
Time frame: Samples will be taken predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: Samples will be taken predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Area under the plasma concentration-time curve from zero up to infinity (AUC(0-inf))
Time frame: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Time to reach a maximum plasma concentration (tmax)
Time frame: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Terminal half-life (t1/2)
Time frame: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Rate constant of elimination (λz)
Time frame: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Apparent total body clearance (CL/f)
Time frame: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Apparent volume of distribution (Vz/F)
Time frame: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
AUC % extrapolation
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Time frame: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose
Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) from the Day 1 of the first treatment period until Safety Follow Up visit
Time frame: From the Day 1 of the first treatment period until Safety Follow Up visit (Day 8)