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Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers

NCT03495739 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-04-12

No results posted yet for this study

Summary

A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers

Conditions

  • Healthy

Interventions

DRUG

RDG-17012 Capsule

Dabigatran Etexilate tosylate 150mg

DRUG

Dabigatran Etexilate Mesylate 150 MG Oral Capsule

Dabigatran Etexilate mesylate 150mg

Sponsors & Collaborators

  • Huons Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-06-01
Completion
2018-12-01

Countries

  • South Korea

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 NCT03495739 on ClinicalTrials.gov