Fasted State Clinical Trial
— LCD18KOfficial 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
| Verified date | April 2014 |
| Source | Desitin Arzneimittel GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Bulgaria: Bulgarian Drug Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Department of Clinical Pharmacology | Sofia |
| Lead Sponsor | Collaborator |
|---|---|
| Desitin Arzneimittel GmbH |
Bulgaria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cmax and AUC(0-tz) of levodopa and carbidopa | Cmax (maximal plasma concentration), AUC (area under the curve) | 12 hours | No |