This study is to find out whether the bioavailability of GB-5001A 280 mg Injection is compared to the comparator drug of Aricept® 5 mg and Aricept® 10 mg which are Film-Coated Tablet when administered in healthy subjects. Also to monitor the adverse events and to ensure the safety of the subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Depending on the cohort, doses will be varied to administer.
Aricept® (donepezil hydrochloride) 5 mg film-coated tablet administered orally as an active comparator
Aricept® (donepezil hydrochloride) 10 mg film-coated tablet administered orally as an active comparator
PT Equilab International
Jakarta, South Jakarta, Indonesia
Pharmacokinetic parameter
Peak plasma concentration during steady state (Cmax,ss)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Minimum plasma concentration during steady state (Cmin,ss)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Average drug concentration at steady state (Cav,ss)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Time to maximum concentration at steady state (Tmax,ss)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Area under the plasma concentration versus time curve during a dosage interval at steady state (AUCτ,ss)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Area under the plasma concentration versus time curve extrapolated to infinite time (AUCinf)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Apparent total body clearance of drug from plasma after oral administration at steady state (CLss/F)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Apparent volume of distribution at steady state (Vss/F)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
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Pharmacokinetic parameter
Plasma half life (t1/2)
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Adverse events
Number of subjects and Incidences with adverse events by Study arm.
Time frame: Day 1 to Day 226