A Phase 1 interventional study of BIBV 308 SE solution and BIBV 308 SE capsule L in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-22.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BIBV 308 SE solution
Drug: BIBV 308 SE capsule L
Drug: BIBV 308 SE capsule S
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
Time frame: up to 5 days after last drug administration
Trough concentration of BIBV 308 SE before doses
Time frame: up to 84 hours
No study locations are listed for this record.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim