NCT01475279

A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin

An Open-Label, Multiple-Dose, Single-Center, Sequential, Inpatient Study to Determine the Effect of T89 on Steady-State Pharmacodynamics of Warfarin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Tasly Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the potential effect of Dantonic on the steady-state pharmacodynamics and pharmacokinetic of warfarin in healthy subjects and safety of the co-administration of Dantonic and warfarin.

Detailed description

Due to a large proportion of patients that could benefit from Dantonic treatment is likely to take warfarin concomitantly. And there is no systematic experience of warfarin drug-drug interaction between Dantonic and warfarin on humans. It is highly relevant to investigate the potential interaction of theses two drugs. Primary endpoint: •The change in INR with T89 (Day 25) compared with that without T89 (Day 18) Secondary endpoints: * The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24 * Safety assessments across all time points

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Warfarin; Dantonic	Individual warfarin dose during the study; 225mg Dantonic b.i.d for one week

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-11-01
• Completion: 2012-01-01
• First posted: 2011-11-21
• Last updated: 2012-11-08

Locations

1 site across 1 country: United States