Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers

NCT01172496

Pulmonary Arterial Hypertension

COMPLETED PHASE1

Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

NCT01153386

Pulmonary Arterial Hypertension

COMPLETED PHASE1

Effect of Food on the Pharmacokinetics of Oral Treprostinil

NCT00963001

Hypertension, Pulmonary Pulmonary Arterial Hypertension

COMPLETED PHASE1

The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

NCT01131845

Pulmonary Arterial Hypertension Renal Dysfunction

COMPLETED PHASE1

Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers

NCT02318758

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

manufacturer #1

treprostinil diethanolamine from manufacturer #1

Group Type ACTIVE_COMPARATOR

Treprostinil diethanolamine

Intervention Type DRUG

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

manufacturer #2

treprostinil diethanolamine from manufacturer #2

Group Type EXPERIMENTAL

Treprostinil diethanolamine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treprostinil diethanolamine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes