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Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

NCT01165476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-04-19

No results posted yet for this study

Summary

The purpose of this study is to compare the bioavailability of a single 1mg dose of treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent facilities.

Conditions

Interventions

DRUG

Treprostinil diethanolamine

sustained release tablets. One 1mg tablet per period. Two total doses.

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Aziz L Laurent, MD · PPD Development, LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01165476 on ClinicalTrials.gov