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Three Times Daily Dosing of UT-15C

NCT ID: NCT01746485

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-07-31

Brief Summary

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To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

Detailed Description

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Conditions

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Healthy

Keywords

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Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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UT-15C

Group Type EXPERIMENTAL

UT-15C

Intervention Type DRUG

Interventions

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UT-15C

Intervention Type DRUG

Other Intervention Names

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treprostinil diethanolamine treprostinil diolamine UT-15C SR

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects
* aged 18-55 years of age;
* weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and
* weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theresa Pham, MD

Role: PRINCIPAL_INVESTIGATOR

PPD Development, LP

Locations

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PPD Development

Austin, Texas, United States

Site Status

Countries

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United States

References

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Jones A, Wang-Smith L, Pham T, Laliberte K. Pharmacokinetics of 3 times a day dosing of oral treprostinil in healthy volunteers. J Cardiovasc Pharmacol. 2014 Mar;63(3):227-32. doi: 10.1097/FJC.0000000000000039.

Reference Type DERIVED
PMID: 24603117 (View on PubMed)

Other Identifiers

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TDE-DU-102

Identifier Type: -

Identifier Source: org_study_id