drugset / Trial / NCT01500122

Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®

NCT01500122 ↗

Phase 1 Completed 12 enrolled MediGene
NaSingle-groupOpen-label

Summary

The primary objectives of the study are: * To compare the pharmacokinetic profiles of RhuDex administered as two novel oral formulations * To identify the lead formulation and optimise the pharmacokinetic profile by modifying the quantitative composition of that formulation * Optional: To assess the intravenous pharmacokinetics of RhuDex following administration of an IV microtracer of \[14C\]RhuDex

Timeline

Start
2011-12
Primary completion
2012-03
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject RhuDex® Small molecule — Oral

Indications

No indication recorded.