Bioequivalence of Two Different Capsule Types of Dabigatran
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of
dabigatran etexilate made from two different drug product batches.
The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved
capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using
a new capsule shell (Capsugel). The test batch is the drug product intended for future
commercial use.