Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01165476
• Date of registration: 15/07/2010
• Prospective Registration: No
• Primary sponsor: United Therapeutics
• Public title: Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities
• Scientific title: An Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed State
• Date of first enrolment: July 2010
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01165476
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Aziz L Laurent, MD
• Affiliation: PPD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Treprostinil diethanolamine

Primary Outcome(s)

Treprostinil pharmacokinetics [Time Frame: 36 hours]

Secondary Outcome(s)

Clinical lab values [Time Frame: Days 0, 7 and 9]

Adverse event monitoring [Time Frame: From signing of ICF to end of study]

Secondary ID(s)

TDE-PH-121

Source(s) of Monetary Support

Please refer to primary and secondary sponsors