HealthyPhase 1NCT02264132
Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers
A Phase 1 study testing Pramipexole ER tablet and Pramipexole IR tablet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters Relative BA at steady state: Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d. Pramipexole 1.5 mg ER tablet q.d. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pramipexole ER tablet and Pramipexole IR tablet
- 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
- Sep 2006to Nov 2006
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects participating in the study are healthy male volunteers
- Age between 20 and 40 years
- Body mass index (BMI) between 17.6 and 26.4 kg/m2
- All volunteers must give written informed consent before screening to participate in this study and before first drug administration on Day 1 at Visit 2
Who cannot join
- Any findings of the medical examination (including blood pressure, pulse rate, ECG, and laboratory test parameters) of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy), psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 18Show fewer
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than ten half-lives of the respective drug before the administration of investigational products
- Use of any drugs which might influence the results of the trial within 7 days before the start of drug administration in the study or during the study period
- Participation in another trial with an investigational drug (within 4 months before the start of drug administration)
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day and who cannot refrain from smoking at the trial site)
- Alcohol abuse (>40 g/day)
- Drug abuse
- Blood donation (≥100 mL within 4 weeks before drug administration or during the trial)
- Excessive physical activities from 7 days before the start of drug administration to the end of this study
- Any positive results in hepatitis B surface antigen (HBsAg), anti hepatitis B core (HBc) antibodies, anti hepatitis C virus (HCV) antibodies and human immunodeficiency virus (HIV) test
- The following exclusion criteria are of special interest for this study:
- Hypersensitivity to pramipexole or other dopamine agonists
- Supine blood pressure at screening of systolic <110 mmHg and diastolic <60 mmHg
About this study
Official title: A Multiple Dose Study of Pramipexole With Increasing Doses (0.375 mg to 1.5 mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375 mg ER Tablet q.d. Versus 0.125 mg Immediate Release (IR) Tablet t.i.d. and 1.5 mg ER Tablet q.d. Versus 0.5 mg IR Tablet t.i.d. in Japanese Healthy Male Volunteers
The objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters
Relative BA at steady state:
- Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.
- Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.
Dose proportionality of pharmacokinetic parameters:
- Pramipexole ER dosages from 0.375 to 1.5 mg q.d.
- Conditions
- Healthy
- Being tested
- Pramipexole ER tablet, Pramipexole IR tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole ER tabletDrug
Pramipexole IR tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole ER tablet versus Pramipexole IR tablet | Experimental | Not described Receives: Drug: Pramipexole ER tablet; Drug: Pramipexole IR tablet |
| Pramipexole IR tablet versus Pramipexole ER tablet | Experimental | Not described Receives: Drug: Pramipexole ER tablet; Drug: Pramipexole IR tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Measured: up to day 5
AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
Measured: up to 24 hours after drug administration
Secondary outcomes (21)
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Relative BA
Measured: up to 24 hours after drug administration
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Dose proportionality (only for ER)
Measured: up to 24 hours after drug administration
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Dose proportionality (only for ER)
Measured: up to day 5
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Dose proportionality (only for ER)
Measured: up to 24 hours after drug administration
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Measured: up to 24 hours after drug administration
AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
Measured: up to 24 hours after drug administration
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Measured: up to day 5
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state)
Measured: up to day 5
PTF (peak-trough fluctuation)
Measured: up to day 5
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state)
Measured: up to day 5
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Measured: up to day 5
Cavg (average concentration of the analyte in plasma at steady state)
Measured: up to day 5
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: up to day 5
CL/F,ss (apparent clearance of the analyte in plasma at steady state after
Measured: up to day 5
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Measured: up to day 5
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)
Measured: up to day 5
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Measured: up to 24 hours after drug administration
Ae0-8,ss for IR (amount of analyte that is eliminated in urine from 0 to 8 hours at steady state)
Measured: up to 8 hours after drug administration
AUC0-8,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 hours at steady state)
Measured: up to 8 hours after drug administration
Number of subjects with adverse events
Measured: up to 7 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2006
- Primary completionNov 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.
- 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
- 24 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
- NCT02264132
- Sponsor's protocol ID
- 248.607
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study of Pramipexole With Increasing Doses (0.375 mg to 1.5 mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375 mg ER Tablet q.d. Versus 0.125 mg Immediate Release (IR) Tablet t.i.d. and 1.5 mg ER Tablet q.d. Versus 0.5 mg IR Tablet t.i.d. in Japanese Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02264132
- Acronym / sponsor ID
- 248.607
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2006 (actual)
- First posted
- 15 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 objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters
Relative BA at steady state:
- Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.
- Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.
Dose proportionality of pharmacokinetic parameters:
- Pramipexole ER dosages from 0.375 to 1.5 mg q.d.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramipexole ER tablet versus Pramipexole IR tablet | Experimental | Drug: Pramipexole ER tablet, Drug: Pramipexole IR tablet |
| Pramipexole IR tablet versus Pramipexole ER tablet | Experimental | Drug: Pramipexole ER tablet, Drug: Pramipexole IR tablet |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All subjects participating in the study are healthy male volunteers
- Age between 20 and 40 years
- Body mass index (BMI) between 17.6 and 26.4 kg/m2
- All volunteers must give written informed consent before screening to participate in this study and before first drug administration on Day 1 at Visit 2
Key exclusion criteria (18 listed)
- Any findings of the medical examination (including blood pressure, pulse rate, ECG, and laboratory test parameters) of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy), psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or 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 |
|---|---|---|
| Pramipexole ER tablet | Drug | Pramipexole ER tablet versus Pramipexole IR tablet, Pramipexole IR tablet versus Pramipexole ER tablet |
| Pramipexole IR tablet | Drug | Pramipexole ER tablet versus Pramipexole IR tablet, Pramipexole IR tablet versus Pramipexole ER tablet |
Primary outcome
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Time frame: up to day 5
AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
Time frame: up to 24 hours after drug administration
21 secondary outcomes
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Time frame: up to 24 hours after drug administration
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Time frame: up to 24 hours after drug administration
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time frame: up to day 5
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Time frame: up to 24 hours after drug administration
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Time frame: up to 24 hours after drug administration
AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
Time frame: up to 24 hours after drug administration
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time frame: up to day 5
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state)
Time frame: up to day 5
PTF (peak-trough fluctuation)
Time frame: up to day 5
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state)
Time frame: up to day 5
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: up to day 5
Cavg (average concentration of the analyte in plasma at steady state)
Time frame: up to day 5
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to day 5
CL/F,ss (apparent clearance of the analyte in plasma at steady state after
Time frame: up to day 5
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Time frame: up to day 5
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)
Time frame: up to day 5
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Time frame: up to 24 hours after drug administration
Ae0-8,ss for IR (amount of analyte that is eliminated in urine from 0 to 8 hours at steady state)
Time frame: up to 8 hours after drug administration
AUC0-8,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 hours at steady state)
Time frame: up to 8 hours after drug administration
Number of subjects with adverse events
Time frame: up to 7 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 5
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 15 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Pramipexole ER tablet and Pramipexole IR 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 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 15 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?
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours) (time frame: up to day 5). 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 15 Oct 2014.