NCT04592822

A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition

A Single Dose, Randomized, Open Label, Two-Treatment, Two-Sequence, Two-Period, Crossover Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hong Kong WD Pharmaceutical Co., Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Anticoagulant

Interventions

Type	Name	Description
DRUG	WD-1602	dabigatran etexilate mesylate granules for oral suspension
DRUG	Pradaxa®	dabigatran etexilate capsules

Timeline

• Start date: 2021-01-06
• Primary completion: 2021-06-06
• Completion: 2021-12-06
• First posted: 2020-10-19
• Last updated: 2020-11-02

Regulatory

• FDA-regulated drug study