Open-label, Pharmacokinetics, Safety, and Tolerability Study of a Single Topical Dose of GOPRELTO® Nasal Solution for the Induction of Local Anesthesia in Pediatric Subjects From ≥12 Years to <17 Years of Age
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety, tolerability, and dosing of GOPRELTO® as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.
A Phase-1 Study Comparing the Pharmacokinetics of Intranasal RX0041-002 in Subjects With Severe Renal Impairment and Subjects With Normal Renal Function
The primary objective of this study is to evaluate the potential effect of renal impairment on the systemic pharmacokinetics of acute Intranasal RX0041-002. The secondary objective is to evaluate the safety and tolerability of acute Intranasal RX0041-002 in subjects with normal renal function and severe renal impairment.
A Phase-1 Study Comparing the Pharmacokinetics of Intranasal RX0041-002 in Hepatic-Impaired Individuals and Subjects With Normal Hepatic Function
The primary objective of this study is to evaluate the potential effect of hepatic impairment on the systemic pharmacokinetics of RX0041-002 following single dose intranasal administration. The secondary objective is to evaluate the safety and tolerability of intranasal RX0041-002 in subjects with normal hepatic function and hepatic impairment.
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