Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

NCT01165476 | Completed Phase 1

• 1 other identifier: TDE-PH-121
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Pulmonary Arterial Hypertension

Keywords

treprostinil; bioavailability; bioequivalence

Outcome Measures

Primary Outcomes (1)

• Treprostinil pharmacokinetics

  Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.

  36 hours

Secondary Outcomes (2)

• Clinical lab values

  Days 0, 7 and 9

• Adverse event monitoring

  From signing of ICF to end of study

Study Arms (2)

manufacturer #1

ACTIVE COMPARATOR

treprostinil diethanolamine from manufacturer #1

Drug: Treprostinil diethanolamine

manufacturer #2

EXPERIMENTAL

treprostinil diethanolamine from manufacturer #2

Drug: Treprostinil diethanolamine

Interventions

Treprostinil diethanolamine DRUG

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

manufacturer #1; manufacturer #2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening
• Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (1)

PPD Development

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aziz L Laurent, MD

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 19, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 19, 2011

Record last verified: 2011-04

Locations

US (1)