Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Plasma total exposure (AUCτ,ss)
Time frame: up to 168 hours after each drug administration
Urine total exposure (Aeτ,ss)
Time frame: up to 168 hours after each drug administration
Plasma maximum exposure (Cmax,ss)
Time frame: up to 168 hours after each drug administration
Plasma minimum exposure (Cmin,ss)
Time frame: up to 168 hours after each drug administration
Plasma average concentration (Cavg)
Time frame: up to 168 hours after each drug administration
Plasma peak to trough fluctuation (PTF)
Time frame: up to 168 hours after each drug administration
AUC0-6,11 for the immediate release (IR) formulation
Time frame: day 7 of visit 2
Cmax for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
Cmin for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
tmax for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
Urinary excretion (Ae) for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
tmax,4 for the SR formulation
Time frame: up to 96 hours after drug administration in visit 3-5, 7 and 9
t1/2,4 for the SR formulation
Time frame: up to 96 hours after drug administration in visit 9
Urinary excretion (Ae) for the SR formulation
Time frame: up to 168 hours after drug administration
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Time frame: up to 8 days after last drug administration
Assessment of global tolerability by investigator on a 5-point scale
Time frame: at the end of each of the visits 2 to 9