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Pharmacokinetic Study With Levodopa-carbidopa Fixed-dose Products in Healthy Subjects After Oral Administration (LCD18K)

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ClinicalTrials.gov Identifier: NCT02116465
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH

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.


Condition or disease Intervention/treatment Phase
Fasted State Drug: Levodopa Carbidopa immediate release tablets Phase 1

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : March 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Levodopa Carbidopa 100/25 tablets Test 1
single oral dose of levodopa carbidopa immediate release tablets
Drug: Levodopa Carbidopa immediate release tablets
oral administration
Other Names:
  • isicom 100/25 mg
  • Nacom 100/25 mg

Active Comparator: Levodopa Carbidopa 100/25 tablets Ref. 1
single oral dose of levodopa carbidopa immediate release tablets
Drug: Levodopa Carbidopa immediate release tablets
oral administration
Other Names:
  • isicom 100/25 mg
  • Nacom 100/25 mg

Active Comparator: Levodopa Carbidopa 100/25 tablets Test 2
single oral dose of levodopa carbidopa immediate release tablets
Drug: Levodopa Carbidopa immediate release tablets
oral administration
Other Names:
  • isicom 100/25 mg
  • Nacom 100/25 mg

Active Comparator: Levodopa Carbidopa 100/25 tablets Ref. 2
single oral dose of levodopa carbidopa immediate release tablets
Drug: Levodopa Carbidopa immediate release tablets
oral administration
Other Names:
  • isicom 100/25 mg
  • Nacom 100/25 mg




Primary Outcome Measures :
  1. Cmax and AUC(0-tz) of levodopa and carbidopa [ Time Frame: 12 hours ]
    Cmax (maximal plasma concentration), AUC (area under the curve)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116465


Locations
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Bulgaria
Department of Clinical Pharmacology
Sofia, Bulgaria, 1527
Sponsors and Collaborators
Desitin Arzneimittel GmbH

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Responsible Party: Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT02116465     History of Changes
Other Study ID Numbers: LCD-018/K
2013-003175-35 ( EudraCT Number )
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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Carbidopa
Carbidopa, levodopa drug combination
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists