drugset / Trial / NCT00532844
A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction
RandomizedCrossoverOpen-labelTreatment
Summary
This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and sapropterin dihydrochloride alone.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-11
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin C | Other / unclassified | 500 mg | Oral |
| Subject | sapropterin | Unknown | 5 mg/kg | Oral |
Indications
No indication recorded.