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

NCT02116465 | Completed Phase 1

• 2 other identifiers: LCD-018/K2013-003175-35
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasted State

Outcome Measures

Primary Outcomes (1)

• Cmax and AUC(0-tz) of levodopa and carbidopa

  Cmax (maximal plasma concentration), AUC (area under the curve)

  12 hours

Study Arms (4)

Levodopa Carbidopa 100/25 tablets Test 1

ACTIVE COMPARATOR

single oral dose of levodopa carbidopa immediate release tablets

Drug: Levodopa Carbidopa immediate release tablets

Levodopa Carbidopa 100/25 tablets Ref. 1

ACTIVE COMPARATOR

single oral dose of levodopa carbidopa immediate release tablets

Drug: Levodopa Carbidopa immediate release tablets

Levodopa Carbidopa 100/25 tablets Test 2

ACTIVE COMPARATOR

single oral dose of levodopa carbidopa immediate release tablets

Drug: Levodopa Carbidopa immediate release tablets

Levodopa Carbidopa 100/25 tablets Ref. 2

ACTIVE COMPARATOR

single oral dose of levodopa carbidopa immediate release tablets

Drug: Levodopa Carbidopa immediate release tablets

Interventions

Levodopa Carbidopa immediate release tablets DRUG

oral administration

Also known as: isicom 100/25 mg, Nacom 100/25 mg

Levodopa Carbidopa 100/25 tablets Ref. 1; Levodopa Carbidopa 100/25 tablets Ref. 2; Levodopa Carbidopa 100/25 tablets Test 1; Levodopa Carbidopa 100/25 tablets Test 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead

Study Sites (1)

Department of Clinical Pharmacology

Sofia, 1527, Bulgaria

Location

MeSH Terms

Conditions

Fasting

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 17, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

BU (1)