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A Healthy Volunteer Study to Evaluate for a Single Dose of 4 Different Tablets of DPOC-4088 the Absorption and Elimination From the Body and the Potential Effect on Blood Clotting

NCT01347203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-07-07

No results posted yet for this study

Summary

This will be a study existing of 4 periods, to evaluate for a single dose of 4 different tablets of DPOC-4088 the absorption and elimination from the body and the potential effect on blood clotting. The differences between the tablets are the dose (100 or 200 mg) and the rate of release of DPOC-4088 from the tablet (16 or 20 hours). The allocation of the tablets in each period will be determined by chance but is known upfront.

Conditions

  • Deep Vein Thrombosis Leg

Interventions

DRUG

DPOC-4088

A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation A = 16 hr release formulation)

DRUG

DPOC-4088

A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation A = 16 hr release formulation)

DRUG

DPOC-4088

A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation B = 20 hr release formulation)

DRUG

DPOC-4088

A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation B = 20 hr release formulation)

Sponsors & Collaborators

  • Diakron Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Luc M Van Bortel, Prof. dr. · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Belgium

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 NCT01347203 on ClinicalTrials.gov