Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Treatment A - fixed dose combination
Treatment B - Monocomponent
Treatment B -Monocomponent
AUC0-∞ (total area under the plasma drug concentration-time curve from time zero to infinity)
Time frame: up to 96 hours post-dose
Cmax (maximum drug plasma concentration)
Time frame: up to 96 hours post-dose
Amount of Hydrochlorothiazide (HCTZ) excreted in urine over 48 hours (Ae(0-48h))
Time frame: 0-6, 6-12, 12-24, 24-32, 32-48 hours post-dose
tmax (time to achieve Cmax)
Time frame: up to 96 hours post-dose
t1/2 (apparent terminal elimination half-life)
Time frame: up to 96 hours post-dose
CLtot/f (total clearance of a drug from plasma, divided by bioavailability)
Time frame: up to 96 hours post-dose
MRTtot (mean time of residence of drug molecules in the body)
Time frame: up to 96 hours post-dose
Vz/f (apparent volume of distribution during terminal phase)
Time frame: up to 96 hours post-dose
Number of patients with adverse events
Time frame: Up to 62 days
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