HealthyPhase 1NCT02261090
Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers
A Phase 1 study testing Formulation B: Pramipexole Slow release (SR) tablet, Formulation C: Pramipexole Slow release tablet and Formulation D: Pramipexole Slow release tablet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Formulation B: Pramipexole Slow release (SR) tablet, Formulation C: Pramipexole Slow release tablet and Formulation D: Pramipexole Slow release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Sep 2004
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants in the study should be healthy males
- Participants should be ranging from 21 to 50 years of age
- Body mass index (BMI) within 18.5 to 29.9 kg/m2
- In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Who cannot join
- 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
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 20Show fewer
- 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
- Hypersensitivity to pramipexole, or other dopamine agonists
- Supine blood pressure at screening of systolic < 110 mmHg and diastolic < 60 mmHg
- A haemoglobin value at screening of less than 13.5 g/dl (usual lower limit of normal for males: 12.6 g/mL)
- Subjects involved in passenger transport or operation of dangerous machines
About this study
Official title: A Multiple Dose Seven-way Cross-over Formulation-finding Study Comparing the Oral Bioavailability of Seven Prototype Slow-release Formulations With 0.75 mg Pramipexole (Four Days Each) to Immediate-release Tablets at Steady State in Healthy Male Volunteers
Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets
- Conditions
- Healthy
- Being tested
- Formulation B: Pramipexole Slow release (SR) tablet, Formulation C: Pramipexole Slow release tablet, Formulation D: Pramipexole Slow release tablet, Formulation E: Pramipexole Slow release tablet, Formulation F: Pramipexole Slow release tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation B: Pramipexole Slow release (SR) tabletDrug
Formulation C: Pramipexole Slow release tabletDrug
Formulation D: Pramipexole Slow release tabletDrug
Formulation E: Pramipexole Slow release tabletDrug
Formulation F: Pramipexole Slow release tabletDrug
Formulation G: Pramipexole Slow release tabletDrug
Formulation H: Pramipexole Slow release tabletDrug
Pramipexole immediate release (IR) tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Formulation B | Experimental | Slow release (SR) tablet Receives: Drug: Formulation B: Pramipexole Slow release (SR) tablet |
| Formulation C | Experimental | SR tablet Receives: Drug: Formulation C: Pramipexole Slow release tablet |
| Formulation D | Experimental | SR tablet Receives: Drug: Formulation D: Pramipexole Slow release tablet |
| Formulation E | Experimental | SR tablet Receives: Drug: Formulation E: Pramipexole Slow release tablet |
| Formulation F | Experimental | SR tablet Receives: Drug: Formulation F: Pramipexole Slow release tablet |
| Formulation G | Experimental | SR tablet Receives: Drug: Formulation G: Pramipexole Slow release tablet |
| Formulation H | Experimental | SR tablet Receives: Drug: Formulation H: Pramipexole Slow release tablet |
| immediate release (IR) formulation | Active comparator | Not described Receives: Drug: Pramipexole immediate release (IR) tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma total exposure (AUCτ,ss)
Measured: up to 168 hours after each drug administration
Urine total exposure (Aeτ,ss)
Measured: up to 168 hours after each drug administration
Plasma maximum exposure (Cmax,ss)
Measured: up to 168 hours after each drug administration
Plasma minimum exposure (Cmin,ss)
Measured: up to 168 hours after each drug administration
Plasma average concentration (Cavg)
Measured: up to 168 hours after each drug administration
Plasma peak to trough fluctuation (PTF)
Measured: up to 168 hours after each drug administration
Secondary outcomes (12)
AUC0-6,11 for the immediate release (IR) formulation
Measured: day 7 of visit 2
Cmax for the IR formulation
Measured: up to 168 hours after drug administration in visit 2
Cmin for the IR formulation
Measured: up to 168 hours after drug administration in visit 2
tmax for the IR formulation
Measured: up to 168 hours after drug administration in visit 2
Urinary excretion (Ae) for the IR formulation
Measured: up to 168 hours after drug administration in visit 2
tmax,4 for the SR formulation
Measured: up to 96 hours after drug administration in visit 3-5, 7 and 9
t1/2,4 for the SR formulation
Measured: up to 96 hours after drug administration in visit 9
Urinary excretion (Ae) for the SR formulation
Measured: up to 168 hours after drug administration
Number of subjects with adverse events
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Measured: up to 8 days after last drug administration
Assessment of global tolerability by investigator on a 5-point scale
Measured: at the end of each of the visits 2 to 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJun 2004
- Primary completionSep 2004
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
- 14 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
- NCT02261090
- Sponsor's protocol ID
- 248.529
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Seven-way Cross-over Formulation-finding Study Comparing the Oral Bioavailability of Seven Prototype Slow-release Formulations With 0.75 mg Pramipexole (Four Days Each) to Immediate-release Tablets at Steady State in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02261090
- Acronym / sponsor ID
- 248.529
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Sep 2004 (actual)
- First posted
- 10 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.
Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Formulation B | Experimental | Drug: Formulation B: Pramipexole Slow release (SR) tabletSlow release (SR) tablet |
| Formulation C | Experimental | Drug: Formulation C: Pramipexole Slow release tabletSR tablet |
| Formulation D | Experimental | Drug: Formulation D: Pramipexole Slow release tabletSR tablet |
| Formulation E | Experimental | Drug: Formulation E: Pramipexole Slow release tabletSR tablet |
| Formulation F | Experimental | Drug: Formulation F: Pramipexole Slow release tabletSR tablet |
| Formulation G | Experimental | Drug: Formulation G: Pramipexole Slow release tabletSR tablet |
| Formulation H | Experimental | Drug: Formulation H: Pramipexole Slow release tabletSR tablet |
| immediate release (IR) formulation | Active comparator | Drug: Pramipexole immediate release (IR) tablets |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All participants in the study should be healthy males
- Participants should be ranging from 21 to 50 years of age
- Body mass index (BMI) within 18.5 to 29.9 kg/m2
- In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Key exclusion criteria (20 listed)
- 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
- Chronic or relevant acute infections
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 |
|---|---|---|
| Formulation B: Pramipexole Slow release (SR) tablet | Drug | Formulation B |
| Formulation C: Pramipexole Slow release tablet | Drug | Formulation C |
| Formulation D: Pramipexole Slow release tablet | Drug | Formulation D |
| Formulation E: Pramipexole Slow release tablet | Drug | Formulation E |
| Formulation F: Pramipexole Slow release tablet | Drug | Formulation F |
| Formulation G: Pramipexole Slow release tablet | Drug | Formulation G |
| Formulation H: Pramipexole Slow release tablet | Drug | Formulation H |
| Pramipexole immediate release (IR) tablets | Drug | immediate release (IR) formulation |
Primary outcome
Plasma total exposure (AUCτ,ss)
Time frame: up to 168 hours after each drug administration
Urine total exposure (Aeτ,ss)
Time frame: up to 168 hours after each drug administration
Plasma maximum exposure (Cmax,ss)
Time frame: up to 168 hours after each drug administration
Plasma minimum exposure (Cmin,ss)
Time frame: up to 168 hours after each drug administration
Plasma average concentration (Cavg)
Time frame: up to 168 hours after each drug administration
Plasma peak to trough fluctuation (PTF)
Time frame: up to 168 hours after each drug administration
12 secondary outcomes
AUC0-6,11 for the immediate release (IR) formulation
Time frame: day 7 of visit 2
Cmax for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
Cmin for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
tmax for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
Urinary excretion (Ae) for the IR formulation
Time frame: up to 168 hours after drug administration in visit 2
tmax,4 for the SR formulation
Time frame: up to 96 hours after drug administration in visit 3-5, 7 and 9
t1/2,4 for the SR formulation
Time frame: up to 96 hours after drug administration in visit 9
Urinary excretion (Ae) for the SR formulation
Time frame: up to 168 hours after drug administration
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital signs
Time frame: up to 8 days after last drug administration
Assessment of global tolerability by investigator on a 5-point scale
Time frame: at the end of each of the visits 2 to 9
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 10 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 Formulation B: Pramipexole Slow release (SR) tablet, Formulation C: Pramipexole Slow release tablet and Formulation D: Pramipexole Slow release tablet 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 20 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 10 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?
Plasma total exposure (AUCτ,ss) (time frame: up to 168 hours after each drug administration). The study lists 6 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 10 Oct 2014.