Healthy Volunteers Clinical Trial
Official title:
A Single Oral Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of Radiprodil in Adult Healthy Volunteers
To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy adult subjects.
UP0027 is a Phase 1, single-center, open-label study to investigate the safety,
tolerability, and PK profile of radiprodil in healthy adult male and female subjects after a
single fasting oral dose of radiprodil 30 mg suspension formulation. A total of 10 subjects
will be enrolled in the study.
The primary objective of the study is to evaluate the PK profile of oral radiprodil in
suspension form in healthy adult subjects.
The secondary objective of the study is to evaluate the safety and tolerability of oral
radiprodil in suspension form in healthy adult subjects.
The exploratory objectives of the study are to evaluate the comparative PK profile of
radiprodil from samples collected using 2 alternative microsampling techniques (MITRAâ„¢ and
Drummond capillary tubes) with that of conventional venous blood samples, and to test the
perception of the taste and texture of the oral radiprodil suspension.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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