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Clinical Trial Summary

This study will be a single-center, randomized, single-dose, open-label, two-treatment, two-period, two-sequence crossover bioequivalence study to compare the rate and extent of absorption of WD-1602 granule formulation (WD Pharma) to the reference drug Pradaxa® capsule (BI, Germany) under fed conditions in healthy subjects.


Clinical Trial Description

The study will comprise of a medical Screening visit, two 2-night (3-day) Treatment Periods, 2 outpatient visits, and a Follow-up visit. Each Treatment visit will be separated by a washout of up to 7 days. The Follow-up visit will occur approximately 7 days (±1) following the last study drug administration. The duration of subject participation, including screening, will be approximately 8 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04592822
Study type Interventional
Source Hong Kong WD Pharmaceutical Co., Limited
Contact
Status Not yet recruiting
Phase Phase 1
Start date January 6, 2021
Completion date December 6, 2021

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