HealthyPhase 1NCT00415740
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
A Phase 1 study testing ELC200 (carbidopa+levodopa+entacapone) in people with Healthy, run by Novartis at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ELC200 (carbidopa+levodopa+entacapone)
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- May 2006to not given
- 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
- Healthy male and female subjects age 18 to 55 years of age included, and in good health
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the normal ranges
- Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
- Female subjects must have undergone hysterectomy, or must be postmenopausal.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
- Significant illness within two weeks prior to dosing
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- Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Women of child bearing potential ( WOCBP)
- History or presence of glaucoma or any suspicious undiagnosed skin lesions
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 12.5 mg Carbidopa, 50 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 12.5 mg Carbidopa and 50 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fasting Conditions
The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers.
- Conditions
- Healthy
- Being tested
- ELC200 (carbidopa+levodopa+entacapone)
- Keywords
- Bioequivalence, bioavailability, carbidopa, levodopa, entacapone, fasting, Healthy volunteers study
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELC200 (carbidopa+levodopa+entacapone)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence between 12.5mg carbidopa/50 mg levodopa/100 mg entacapone single dose combination and 12.5 mg carbidopa/50 mg levodopa single dose combination plus 200 mg entacapone single dose when administered under fasted conditions
Secondary outcomes (1)
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415740
- Sponsor's protocol ID
- CELC200A2101
- Status last verified
- Jun 2007
- First submitted
- 22 Dec 2006
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 12.5 mg Carbidopa, 50 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 12.5 mg Carbidopa and 50 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00415740
- Acronym / sponsor ID
- CELC200A2101
- Conditions
- Healthy
- Keywords
- Bioequivalence, bioavailability, carbidopa, levodopa, entacapone, fasting, Healthy volunteers study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 25 Dec 2006 (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 purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects age 18 to 55 years of age included, and in good health
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the normal ranges
- Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
- Female subjects must have undergone hysterectomy, or must be postmenopausal.
Key exclusion criteria (12 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
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 |
|---|---|---|
| ELC200 (carbidopa+levodopa+entacapone) | Drug | – |
Primary outcome
Bioequivalence between 12.5mg carbidopa/50 mg levodopa/100 mg entacapone single dose combination and 12.5 mg carbidopa/50 mg levodopa single dose combination plus 200 mg entacapone single dose when administered under fasted conditions
1 secondary outcome
Safety and tolerability
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 22 Jun 2007.
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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.
Novartis principal investigator
Investigator site
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 ELC200 (carbidopa+levodopa+entacapone) in people with Healthy, run by Novartis at 1 site in Germany.
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 4 inclusion and 12 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 22 Jun 2007. 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 Germany. 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?
Bioequivalence between 12.5mg carbidopa/50 mg levodopa/100 mg entacapone single dose combination and 12.5 mg carbidopa/50 mg levodopa single dose combination plus 200 mg entacapone single dose when administered under fasted conditions. 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 22 Jun 2007.