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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

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).

Interventions

  • Drug: Levodopa Carbidopa immediate release tablets
    • oral administration

Arms, Groups and Cohorts

  • Active Comparator: Levodopa Carbidopa 100/25 tablets Test 1
    • single oral dose of levodopa carbidopa immediate release tablets
  • Active Comparator: Levodopa Carbidopa 100/25 tablets Ref. 1
    • single oral dose of levodopa carbidopa immediate release tablets
  • Active Comparator: Levodopa Carbidopa 100/25 tablets Test 2
    • single oral dose of levodopa carbidopa immediate release tablets
  • Active Comparator: Levodopa Carbidopa 100/25 tablets Ref. 2
    • single oral dose of levodopa carbidopa immediate release tablets

Clinical Trial Outcome Measures

Primary Measures

  • Cmax and AUC(0-tz) of levodopa and carbidopa
    • Time Frame: 12 hours
    • Cmax (maximal plasma concentration), AUC (area under the curve)

Participating in This Clinical Trial

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
  • Positive alcohol or urine drug test at screening
  • Regular use of any prescription medicine (except for contraceptives) or over-the-counter product, herbal product, hormone supplement, etc. in the 30 days prior to the Screening visit
  • History of alcohol and/or drug abuse and/or daily use of > 30 g alcohol
  • Smoking more than 10 cigarettes/day or equivalent of other tobacco products
  • Suspicion or evidence that the subject is not trustworthy and reliable
  • Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard.
  • Positive pregnancy test
  • Lactating
  • Female subjects of child-bearing potential not using appropriate contraception in the 3 weeks prior to enrolment until two weeks after the last dose of the trial medication

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Desitin Arzneimittel GmbH
  • Provider of Information About this Clinical Study
    • Sponsor

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