NCT02116465

Pharmacokinetic Study With Levodopa-carbidopa Fixed-dose Products in Healthy Subjects After Oral Administration

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Desitin Arzneimittel GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Fasted State

Interventions

Type	Name	Description
DRUG	Levodopa Carbidopa immediate release tablets	oral administration

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-04-17
• Last updated: 2014-04-17

Locations

1 site across 1 country: Bulgaria