Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic
acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female
subjects ages 12-16 years with heavy menstrual bleeding.