Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
Time frame: up to 84 hours
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: up to 84 hours
Minimum plasma concentration at steady state (Cmin,ss)
Time frame: up to 84 hours
Percent peak-to-trough fluctuation (%PTF)
Time frame: up to 84 hours
Time to maximum plasma concentration in steady state (tmax,ss)
Time frame: up to 84 hours
Mean residence time in steady state (MRT,ss)
Time frame: up to 84 hours
Total plasma clearance (CL/f)
Time frame: up to 84 hours
Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)
Time frame: up to 84 hours
Number of patients with adverse events
Time frame: up to 5 days after last drug administration
Number of patients with clinically significant findings in vital signs
pulse rate, blood pressure
Time frame: up to 5 days after last drug administration
Number of patients with clinically significant findings in laboratory tests
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 5 days after last drug administration
Trough concentration of BIBV 308 SE before doses
Time frame: up to 84 hours