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Keep this study
Lead
United Therapeutics
This open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics following a single 1 mg oral dose of UT-15C SR in healthy volunteers.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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.
Clareo Health | Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil
