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Clinical Trial Summary

The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran.


Clinical Trial Description

Bioequivalence study is a research study that needs to compare the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical dosage form between innovator or reference product and test product when given in healthy subjects at the same dose and strength. The acceptance criteria in bioequivalence study will be done by comparing the pharmacokinetic parameters including maximal plasma concentration (Cmax) time at which the maximum plasma concentration occurs (Tmax) and area under the plasma concentration curve (AUC) either area under the plasma concentration curve from administration to last observed concentration at time t (AUC0-tlast) or area under the plasma concentration curve extrapolated to infinite time (AUC0-∞). Those parameters should be calculated only from the plasma concentration and time curve but cannot use other data obtained from in vitro study. By this reason, it is necessary to conduct the study in healthy subjects ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06441916
Study type Interventional
Source International Bio service
Contact Thanaporn Wongyai, M.Sc.Pharm
Phone 024415211
Email thanaporn.won@mahidol.ac.th
Status Not yet recruiting
Phase Phase 1
Start date September 25, 2024
Completion date November 7, 2024

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