The objective of this study is to establish the relative bioavailability (BA) of two different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation following oral single dose administration in fasting healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)
Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)
Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 16 hours after drug administration
Maximum measured concentration of ranitidine in plasma (Cmax)
Time frame: up to 16 hours after drug administration
Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Time frame: up to 16 hours after drug administration
Time from dosing to the maximum concentration of ranitidine in plasma (tmax)
Time frame: up to 16 hours after drug administration
Terminal rate constant in plasma (λz)
Time frame: up to 16 hours after drug administration
Terminal half-life of ranitidine in plasma (t1/2)
Time frame: up to 16 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
Time frame: up to 16 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: up to 16 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 16 hours after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of patients with adverse events
Time frame: up to 38 days
Global assessment of tolerability by investigator on a 4-point scale
Time frame: 24 hours after drug dosing at the end of each treatment period