Pharmacokinetic Study With Levodopa-carbidopa Fixed-dose Products in Healthy Subjects After Oral Administration
- Conditions
- Fasted State
- Interventions
- Registration Number
- NCT02116465
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Levodopa Carbidopa 100/25 tablets Test 1 Levodopa Carbidopa immediate release tablets single oral dose of levodopa carbidopa immediate release tablets Levodopa Carbidopa 100/25 tablets Ref. 1 Levodopa Carbidopa immediate release tablets single oral dose of levodopa carbidopa immediate release tablets Levodopa Carbidopa 100/25 tablets Test 2 Levodopa Carbidopa immediate release tablets single oral dose of levodopa carbidopa immediate release tablets Levodopa Carbidopa 100/25 tablets Ref. 2 Levodopa Carbidopa immediate release tablets single oral dose of levodopa carbidopa immediate release tablets
- Primary Outcome Measures
Name Time Method Cmax and AUC(0-tz) of levodopa and carbidopa 12 hours Cmax (maximal plasma concentration), AUC (area under the curve)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Clinical Pharmacology
🇧🇬Sofia, Bulgaria