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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Desitin Arzneimittel GmbH
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

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