A Phase 1 interventional study of Epinastine syrup and Epinastine tablets in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-09.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets
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: Epinastine syrup
Drug: Epinastine tablets
Area under the curve (AUC) of plasma concentration (CP)
Time frame: Up to 24 hours after drug administration
Absorption rate Cpmax/AUC
Time frame: Up to 24 hours after drug administration
Peak plasma concentration (Cpmax)
Time frame: Up to 24 hours after drug administration
Time to peak (Tmax)
Time frame: Up to 24 hours after drug administration
Drug half - life (T1/2)
Time frame: Up to 24 hours after drug administration
Number of participants with adverse events
Time frame: Up to 24 hours after last drug administration
Number of participants withdrawn or discontinued due to safety reasons
Time frame: Up to 24 hours after last drug administration
Number of participants with abnormal findings in physical examination
Time frame: Up to 24 hours after last drug administration
Number of participants with clinically significant findings in vital signs
Time frame: Up to 24 hours after last drug administration
No study locations are listed for this record.
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim