Healthy VolunteersPhase 4PHOE10903NCT01327261
Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers
A Phase 4 study testing Levodopa + benserazide in people with Healthy Volunteers, run by University of Buenos Aires.
Trial summary
A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix S.A.I.C. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Levodopa + benserazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2009
- Phase
- Phase 4
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian Argentinean males and females volunteers aged 21 to 50 years with a body mass index from 19 to 27 kg/m2 were enrolled in this study.
- All volunteers provided written informed consent prior to study initiation.
Who cannot join
- History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease
- Drug or alcohol abuse within 2 years before the start of the study
- Smoking
- HIV, hepatitis B, or hepatitis C infection
- Consumption of any prescribed or over-the-counter drug within 2 weeks before the study or
- Participation in a similar study within the past 6 months. Female subjects were not to be pregnant, planning to become pregnant, or breastfeeding at the time of the study, and were required to use an effective method of contraception (intrauterine device or hormonal method) throughout the study.
About this study
Official title: Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers: A Single- Dose Randomized- Sequence, Open -Label Crossover Study
A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma, Switzerland) to assess their relative bioavailability. After administration of each formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic parameters (AUC, Tmax and Cmax) are compared.
- Conditions
- Healthy Volunteers
- Being tested
- Levodopa + benserazide
- Keywords
- levodopa, benserazide, bioequivalence, pharmacokinetics, A Single - Dose, Randomized- Sequence, Open -Label Crossover Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa + benserazideDrug
Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| Levodopa + benserazide (test formulation) | Experimental | A randomized-sequence, open-label, 2-period crossover study assessing relative bioavailability of two drug products containing the association levodopa + benserazide. Receives: Drug: Levodopa + benserazide |
| Levodopa + benserazide (reference formulation) | Active comparator | Not described Receives: Drug: Levodopa + benserazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide
In order to comply with Argentine regulation for marketing approval this study includes 24 healthy volunteers to investigate whether the relative bioavailability of the test formulation met the regulatory criterion for the assumption of bioequivalence to the branded formulation. After dosing with each formulation, 17 blood samples are taken to measure plasma levodopa concentration by HPLC. With plasma concentration values, pharmacokinetic parameters are calculated and bioequivalence assessed with WinNonLin software.
Measured: Blood samples are collected up to 6 hours after dosing. (day 1)
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety
Volunteers are asked about any discomfort or unusual manifestation they feel. Vital signs are recorded at each sampling time.
Measured: Clinical evaluation are performed up to 6 hours after dosing. (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorios Phoenix S.A.I.C.y F.
- Investigators
- Guillermo Di Girolamo, MD, PhD, Principal investigator, Buenos Aires University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327261
- Sponsor's protocol ID
- Phoenix-Evoser (PHOE 1-0903)
- Acronym
- PHOE10903
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keller GA, Czerniuk P, Bertuola R, Spatz JG, Assefi AR, Di Girolamo G. Comparative bioavailability of 2 tablet formulations of levodopa/benserazide in healthy, fasting volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther. 2011 Apr;33(4):500-10. doi: 10.1016/j.clinthera.2011.04.012.
PubMed 21635995
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers: A Single- Dose Randomized- Sequence, Open -Label Crossover Study
- ClinicalTrials.gov ID
- NCT01327261
- Acronym / sponsor ID
- PHOE10903 / Phoenix-Evoser (PHOE 1-0903)
- Conditions
- Healthy Volunteers
- Keywords
- levodopa, benserazide, bioequivalence, pharmacokinetics, A Single - Dose, Randomized- Sequence, Open -Label Crossover Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Buenos AiresUniversity, hospital or other
- Collaborators
- Laboratorios Phoenix S.A.I.C.y F.
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Apr 2011 (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.
A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma, Switzerland) to assess their relative bioavailability. After administration of each formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic parameters (AUC, Tmax and Cmax) are compared.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levodopa + benserazide (test formulation) | Experimental | Drug: Levodopa + benserazideA randomized-sequence, open-label, 2-period crossover study assessing relative bioavailability of two drug products containing the association levodopa + benserazide. |
| Levodopa + benserazide (reference formulation) | Active comparator | Drug: Levodopa + benserazide |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Caucasian Argentinean males and females volunteers aged 21 to 50 years with a body mass index from 19 to 27 kg/m2 were enrolled in this study.
- All volunteers provided written informed consent prior to study initiation.
Key exclusion criteria (6 listed)
- History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease
- Drug or alcohol abuse within 2 years before the start of the study
- Smoking
- HIV, hepatitis B, or hepatitis C infection
- Consumption of any prescribed or over-the-counter drug within 2 weeks before the study or
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 + benserazideSingle oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water. | Drug | Levodopa + benserazide (reference formulation), Levodopa + benserazide (test formulation) |
Primary outcome
Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide
Time frame: Blood samples are collected up to 6 hours after dosing. (day 1)
In order to comply with Argentine regulation for marketing approval this study includes 24 healthy volunteers to investigate whether the relative bioavailability of the test formulation met the regulatory criterion for the assumption of bioequivalence to the branded formulation. After dosing with each formulation, 17 blood samples are taken to measure plasma levodopa concentration by HPLC. With plasma concentration values, pharmacokinetic parameters are calculated and bioequivalence assessed with WinNonLin software.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety
Time frame: Clinical evaluation are performed up to 6 hours after dosing. (day 1)
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 4 Aug 2011.
- Derived from this study: PubMed 21635995Keller GA, Czerniuk P, Bertuola R, Spatz JG, Assefi AR, Di Girolamo G. Comparative bioavailability of 2 tablet formulations of levodopa/benserazide in healthy, fasting volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther. 2011 Apr;33(4):500-10. doi: 10.1016/j.clinthera.2011.04.012.
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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.
Guillermo Di Girolamo, MD, PhD principal investigator
Buenos Aires University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levodopa + benserazide in people with Healthy Volunteers, run by University of Buenos Aires.
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 2 inclusion and 6 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 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide (time frame: Blood samples are collected up to 6 hours after dosing. (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327261, which also lists 1 linked publication.
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 4 Aug 2011.