Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions
Status:
Recruiting
Trial end date:
2022-03-25
Target enrollment:
Participant gender:
Summary
It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence,
multiple oral dose, crossover comparative bioavailability study of different strengths of
carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal,
healthy adult human subjects under fasting and fed conditions. The primary objective of the
study is to compare the pharmacokinetic profiles between WD-1603 extended-release
formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after
oral administration in fasting and fed conditions in healthy subjects and to compare relative
bioavailability between treatments.
Phase:
Phase 1
Details
Lead Sponsor:
Shanghai WD Pharmaceutical Co., Ltd.
Treatments:
Carbidopa Carbidopa, levodopa drug combination Levodopa