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A Study to Evaluate the Safety and Tolerability of Tecarfarin in Healthy Chinese Volunteers

NCT03652779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-11-21

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated.

Conditions

  • Pharmacokinetic and Pharmacodynamic Profile of Tecarfarin

Interventions

DRUG

Tecarfarin 10mg

Tecarfarin 10mg tablets

DRUG

Tecarfarin 20mg

two tecarfarin 10mg tablets

DRUG

Tecarfarin 30mg

three tecarfarin 10mg tablets

DRUG

Tecarfarin 40mg

four tecarfarin 10mg tablets

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • Jo Jo SH Hai, MBBS · Queen Mary Hospital, Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2019-10-28
Completion
2019-10-28

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652779 on ClinicalTrials.gov