Other Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Bioequivalence Between DopaSnap® (Carbidopa/Levodopa 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet and to Evaluate the Food-Effect of DopaSnap® in Normal Healthy Volunteers
This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:
This will be a single center, bioequivalence and food-effect, open-label study designed to be
conducted in three sequential parts:
- Part I: bioequivalence, food-effect, randomized, open-label, single dose, 3-period,
6-sequence, crossover design.
- Part II: multiple-dose (every 4 hours), open-label, 1-period design.
- Part III: multiple-dose (every 2 hours), open-label, 1-period design.
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