Fasted State
Conditions
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).
Interventions
DRUGLevodopa Carbidopa immediate release tablets
oral administration
Sponsors
Desitin Arzneimittel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax and AUC(0-tz) of levodopa and carbidopa | 12 hours | Cmax (maximal plasma concentration), AUC (area under the curve) |
Countries
Bulgaria
Outcome results
None listed