A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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.