Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

June 30, 2012

Conditions
Formulation Finding
Interventions
DRUG

RhuDex

"Part 1:~Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose~The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions."

Trial Locations (1)

NG11 6JS

Quotient Clinical, Ruddington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MediGene

INDUSTRY

NCT01500122 - Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX® | Biotech Hunter | Biotech Hunter