Fasted StatePhase 1LCD18KNCT02116465
Pharmacokinetic Study With Levodopa-carbidopa Fixed-dose Products in Healthy Subjects After Oral Administration
A Phase 1 study testing Levodopa Carbidopa immediate release tablets in people with Fasted State, run by Desitin Arzneimittel GmbH at 1 site in Bulgaria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasted State
- What is being tested?
- Levodopa Carbidopa immediate release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBulgaria
- Study dates
- Mar 2014to Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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).
- Conditions
- Fasted State
- Being tested
- Levodopa Carbidopa immediate release tablets
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa Carbidopa immediate release tabletsDrug
Also called isicom 100/25 mg, Nacom 100/25 mg
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Levodopa Carbidopa 100/25 tablets Test 1 | Active comparator | single oral dose of levodopa carbidopa immediate release tablets Receives: Drug: Levodopa Carbidopa immediate release tablets |
| Levodopa Carbidopa 100/25 tablets Ref. 1 | Active comparator | single oral dose of levodopa carbidopa immediate release tablets Receives: Drug: Levodopa Carbidopa immediate release tablets |
| Levodopa Carbidopa 100/25 tablets Test 2 | Active comparator | single oral dose of levodopa carbidopa immediate release tablets Receives: Drug: Levodopa Carbidopa immediate release tablets |
| Levodopa Carbidopa 100/25 tablets Ref. 2 | Active comparator | single oral dose of levodopa carbidopa immediate release tablets Receives: Drug: Levodopa Carbidopa immediate release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax and AUC(0-tz) of levodopa and carbidopa
Cmax (maximal plasma concentration), AUC (area under the curve)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasted StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desitin Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116465
- Sponsor's protocol ID
- LCD-018/K
- Other IDs
- 2013-003175-35
- Acronym
- LCD18K
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02116465
- Acronym / sponsor ID
- LCD18K / LCD-018/K
- Conditions
- Fasted State
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Desitin Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Levodopa Carbidopa 100/25 tablets Test 1 | Active comparator | Drug: Levodopa Carbidopa immediate release tabletssingle oral dose of levodopa carbidopa immediate release tablets |
| Levodopa Carbidopa 100/25 tablets Ref. 1 | Active comparator | Drug: Levodopa Carbidopa immediate release tabletssingle oral dose of levodopa carbidopa immediate release tablets |
| Levodopa Carbidopa 100/25 tablets Test 2 | Active comparator | Drug: Levodopa Carbidopa immediate release tabletssingle oral dose of levodopa carbidopa immediate release tablets |
| Levodopa Carbidopa 100/25 tablets Ref. 2 | Active comparator | Drug: Levodopa Carbidopa immediate release tabletssingle oral dose of levodopa carbidopa immediate release tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa Carbidopa immediate release tabletsAlso: isicom 100/25 mg, Nacom 100/25 mgoral administration | Drug | 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 |
Primary outcome
Cmax and AUC(0-tz) of levodopa and carbidopa
Time frame: 12 hours
Cmax (maximal plasma concentration), AUC (area under the curve)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levodopa Carbidopa immediate release tablets in people with Fasted State, run by Desitin Arzneimittel GmbH at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax and AUC(0-tz) of levodopa and carbidopa (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.