NCT00872729 - Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of RP103 Compared to Cystagon® in Patients With Cystinosis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions

Cystinosis

Interventions

DRUG

Cystagon®

"Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.~Duration of Treatment and Dose: Reference Period up to four doses Q6H."

DRUG

RP103

"Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.~Duration of treatment and Dose: Single dose of Test Product at dose equivalent to Reference Product."

Trial Locations (1)

92103

University of California San Diego Medical Center, San Diego