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

Desitin Arzneimittel GmbH1 site in 1 country12 target enrollmentMarch 2014

ConditionsFasted State

InterventionsLevodopa Carbidopa immediate release tablets

Overview

Phase: Phase 1
Intervention: Levodopa Carbidopa immediate release tablets
Conditions: Fasted State
Sponsor: Desitin Arzneimittel GmbH
Enrollment: 12
Locations: 1
Primary Endpoint: Cmax and AUC(0-tz) of levodopa and carbidopa
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

March 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Desitin Arzneimittel GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
•Race: Caucasian
•Age: 18 to 45 years
•Body weight: 50 100 kg
•Body Mass Index: 18 26 kg.m-2
•Healthy based on the screening examination
•Willing and able to provide informed consent

Exclusion Criteria

•Previous participation in this trial or participant in any other trial during the last 90 days
•Donation of blood or plasma during the last 90 days or a history of blood loss exceeding 300 mL within the last 3 months
•History of any clinically relevant allergy including hypersensitivity to levodopa or carbi-dopa and related excipients
•Presence of any acute or chronic infection
•Presence or history of any relevant co-morbidity
•Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
•Clinically relevant ECG-abnormalities, in particular prolonged QTc(F) of \> 450 msec in males and \> 460 msec in females
•Presence of any relevant abnormality in the laboratory safety tests, especially low haemo-globin (\< 120 g/L in females and (\< 136 g/L in males) and increased liver enzymes (2 times the upper limit of the normal range)
•Positive serology for HBsAg or anti HCV
•Positive HIV test