Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg theophylline anhydrous (sustained-release product) by comparing the rate and extent of absorption of theophylline based on both single and multiple-dose profiles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Maximum concentration (Cmax)
Time frame: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)
Time frame: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs at steady state (AUDss)
Time frame: up to 12 hours after last administration of study drug
Percent peak-to-trough fluctuation (%PTF)
Time frame: up to 12 hours after last administration of study drug
Time to maximum concentration (Tmax)
Time frame: up to 36 hours after first drug administration
Apparent terminal half-life (t1/2.z)
Time frame: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs [AUD(0-tlast)], also indicated by AUD, where tlast is the time of the last quantifiable concentration
Time frame: up to 36 hours after first drug administration
Ratio of Cmax and AUDC (Cmax/AUDC)
Time frame: up to 36 hours after first drug administration
Total mean time in the system (MTvsys)
Time frame: up to 36 hours after first drug administration
Maximum concentration at steady state (Cmax,ss)
Time frame: up to 12 hours after last administration of study drug
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Minimum concentration at steady state (Cmin,ss)
Time frame: up to 12 hours after last administration of study drug
Plateau time (T75%Cmax)
Time frame: up to 12 hours after last administration of study drug