Fasted State Clinical Trial
Official title:
Open-label, Two-treatment, 4-period Replicated Crossover Study in Healthy Subjects to Investigate the Plasma Pharmacokinetics of Levodopa and Carbidopa After Oral Administration of Single Doses of Two Fixed-dose Combination Products
The study is carried-out to describe and compare the plasma pharmacokinetics of levodopa and
carbidopa after oral single-dose administration of 100 mg levodopa plus 25 mg carbidopa by
means two fixed combination products (test: Isicom® 100/25 mg; reference: Nacom® 100/25 mg).
Additionally, to describe and compare the safety and tolerability of the two investigational
treatments administered to healthy subjects.
Isicom® 100/25 mg and Sinemet® (Trade name in Germany: Nacom®) 100/25 mg are authorised
fixed-combination products containing 100 mg levodopa plus 25 mg carbidopa. These two
formulations were tested for bioequivalence in 1997 (DESITIN trial № LCD-010/K); based on
the regulatory provisions in place at that time (CPMP/EWP/QWP/1401/98), the two formulations
could be accepted to be bioequivalent.
The present study is proposed to be conducted in order to verify and confirm the
bioequivalence of Isicom® 100/25 mg (test formulation) and Nacom® 100/25 mg (reference
formulation) in agreement with the pertinent regulatory guidance that came in place 2010
(CHMP Guideline On The Investigation Of Bioequivalence - CPMP/EWP/QWP/1401/98- Rev. 1/ Corr
- Jan.2010).
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label