Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.

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Detailed Description

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This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.5 mg treprostinil diethanolamine

Group Type EXPERIMENTAL

Treprostinil diethanolamine

Intervention Type DRUG

Treprostinil diethanolamine sustained release oral tablets.

2.5 mg treprostinil diethanolamine

Group Type EXPERIMENTAL

Treprostinil diethanolamine

Intervention Type DRUG

Treprostinil diethanolamine sustained release oral tablets.

1 mg treprostinil diethanolamine

Group Type EXPERIMENTAL

Treprostinil diethanolamine

Intervention Type DRUG

Treprostinil diethanolamine sustained release oral tablets.

Interventions

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Treprostinil diethanolamine

Treprostinil diethanolamine sustained release oral tablets.

Intervention Type DRUG

Other Intervention Names

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UT-15C

Eligibility Criteria

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Inclusion Criteria

* Subject is healthy and between the ages of 18 and 55 years
* Female subjects must weigh between 55 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 55 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.

Exclusion Criteria

* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
* Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary and/or musculoskeletal disease; glaucoma; a psychiatric disorder or any other chronic disease, whether controlled by medication or not.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes