HealthyPhase 1NCT02260024
In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers
A Phase 1 study testing High fat, high caloric meal, Pramipexole IR tablets and Pramipexole SR C in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High fat, high caloric meal, Pramipexole IR tablets and Pramipexole SR C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Dec 2005
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects as determined by results of the screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥ 18 and ≤ 50 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2
Who cannot join
- Hypersensitivity to pramipexole or to other dopamine agonists
- Supine systolic blood pressure lower than 110 mmHg and supine diastolic blood pressure lower than 60 mmHg at screening
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
Show all 18Show fewer
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on in-house trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
About this study
Official title: A Single Dose Five-way Cross-over Study to Establish an in Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets With 0.375 mg Pramipexole in Healthy Male Volunteers
The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not
- Conditions
- Healthy
- Being tested
- High fat, high caloric meal, Pramipexole IR tablets, Pramipexole SR C, Pramipexole SR C2, Pramipexole SR C2A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat, high caloric mealOther
Pramipexole IR tabletsDrug
Pramipexole SR CDrug
Pramipexole SR C2Drug
Pramipexole SR C2ADrug
Pramipexole SR C2BDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole IR | Active comparator | Not described Receives: Drug: Pramipexole IR tablets |
| Pramipexole SR C2 in the fasted state | Experimental | Not described Receives: Drug: Pramipexole SR C2 |
| Pramipexole SR C2A in the fasted state | Experimental | Not described Receives: Drug: Pramipexole SR C2A |
| Pramipexole SR C2B in the fasted state | Experimental | Not described Receives: Drug: Pramipexole SR C2B |
| Pramipexole SR C in the fasted state | Experimental | Not described Receives: Drug: Pramipexole SR C |
| Pramipexole SR C2 in the fed state | Experimental | Not described Receives: Other: High fat, high caloric meal; Drug: Pramipexole SR C2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)
Measured: Up to 30 hours after drug administration
Cmax (maximum measured concentration of pramipexole in blood plasma)
Measured: Up to 30 hours after drug administration
Secondary outcomes (14)
AUC0-10 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to the median tmax in the fasted state)
Measured: Up to 30 hours after drug administration
AUC0-24 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to 24 h after drug administration),
Measured: Up to 24 hours after drug administration
AUC0-∞ (area under the concentration-time curve of pramipexole in blood plasma over the time interval from 0 extrapolated to infinity),
Measured: Up to 30 hours after drug administration
tmax (time from dosing to the maximum concentration of pramipexole in blood plasma)
Measured: Up to 30 hours after drug administration
λz (terminal rate constant in blood plasma),
Measured: Up to 30 hours after drug administration
t½ (terminal half-life of pramipexole in blood plasma)
Measured: Up to 30 hours after drug administration
MRTpo (mean residence time of pramipexole in the body after oral administration)
Measured: Up to 30 hours after drug administration
CL/F (apparent clearance of pramipexole in the blood plasma after extravascular administration)
Measured: Up to 30 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
Measured: Up to 30 hours after drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Measured: Up to 120 hours after drug administration
Number of subjects with adverse events
Measured: Up to 7 days after last drug administration
Number of subjects with clinically significant findings in vital signs
pulse rate, blood pressure
Measured: Up to 7 days after last drug administration
Number of subjects with clinically significant findings in laboratory parameters
Measured: Up to 7 days after last drug administration
Number of subjects with clinically significant findings in physical examination
Measured: Up to 7 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2005
- Primary completionDec 2005
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260024
- Sponsor's protocol ID
- 248.560
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Five-way Cross-over Study to Establish an in Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets With 0.375 mg Pramipexole in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02260024
- Acronym / sponsor ID
- 248.560
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2005 (actual)
- First posted
- 9 Oct 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 primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pramipexole IR | Active comparator | Drug: Pramipexole IR tablets |
| Pramipexole SR C2 in the fasted state | Experimental | Drug: Pramipexole SR C2 |
| Pramipexole SR C2A in the fasted state | Experimental | Drug: Pramipexole SR C2A |
| Pramipexole SR C2B in the fasted state | Experimental | Drug: Pramipexole SR C2B |
| Pramipexole SR C in the fasted state | Experimental | Drug: Pramipexole SR C |
| Pramipexole SR C2 in the fed state | Experimental | Other: High fat, high caloric meal, Drug: Pramipexole SR C2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects as determined by results of the screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥ 18 and ≤ 50 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2
Key exclusion criteria (18 listed)
- Hypersensitivity to pramipexole or to other dopamine agonists
- Supine systolic blood pressure lower than 110 mmHg and supine diastolic blood pressure lower than 60 mmHg at screening
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| High fat, high caloric meal | Other | Pramipexole SR C2 in the fed state |
| Pramipexole IR tablets | Drug | Pramipexole IR |
| Pramipexole SR C | Drug | Pramipexole SR C in the fasted state |
| Pramipexole SR C2 | Drug | Pramipexole SR C2 in the fasted state, Pramipexole SR C2 in the fed state |
| Pramipexole SR C2A | Drug | Pramipexole SR C2A in the fasted state |
| Pramipexole SR C2B | Drug | Pramipexole SR C2B in the fasted state |
Primary outcome
AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)
Time frame: Up to 30 hours after drug administration
Cmax (maximum measured concentration of pramipexole in blood plasma)
Time frame: Up to 30 hours after drug administration
14 secondary outcomes
AUC0-10 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to the median tmax in the fasted state)
Time frame: Up to 30 hours after drug administration
AUC0-24 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to 24 h after drug administration),
Time frame: Up to 24 hours after drug administration
AUC0-∞ (area under the concentration-time curve of pramipexole in blood plasma over the time interval from 0 extrapolated to infinity),
Time frame: Up to 30 hours after drug administration
tmax (time from dosing to the maximum concentration of pramipexole in blood plasma)
Time frame: Up to 30 hours after drug administration
λz (terminal rate constant in blood plasma),
Time frame: Up to 30 hours after drug administration
t½ (terminal half-life of pramipexole in blood plasma)
Time frame: Up to 30 hours after drug administration
MRTpo (mean residence time of pramipexole in the body after oral administration)
Time frame: Up to 30 hours after drug administration
CL/F (apparent clearance of pramipexole in the blood plasma after extravascular administration)
Time frame: Up to 30 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
Time frame: Up to 30 hours after drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: Up to 120 hours after drug administration
Number of subjects with adverse events
Time frame: Up to 7 days after last drug administration
Number of subjects with clinically significant findings in vital signs
Time frame: Up to 7 days after last drug administration
Number of subjects with clinically significant findings in laboratory parameters
Time frame: Up to 7 days after last drug administration
Number of subjects with clinically significant findings in physical examination
Time frame: Up to 7 days after last drug administration
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 9 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High fat, high caloric meal, Pramipexole IR tablets and Pramipexole SR C in people with Healthy, run by Boehringer Ingelheim.
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 18 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 9 Oct 2014. 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 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?
AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration) (time frame: Up to 30 hours after drug administration). The study lists 2 primary outcomes in all. 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 9 Oct 2014.