HealthyPhase 1NCT01214109
Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers
A Phase 1 study testing pramipexole extended release and pramipexole immediate release in people with Healthy, run by Boehringer Ingelheim at 1 site in China.
Trial summary
To establish bioequivalence at steady state of: 1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pramipexole extended release and pramipexole immediate release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
- Age older than or equal 18 and Age younger than or equal 40 years
- Body Mass Index larger than or equal 19 and Body Mass Index less than or equal 24kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
Who cannot join
- Any finding of the medical examination (including Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
Show all 21Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (longer than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial up to 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 one months prior to administration or during the trial
- Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 40 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- 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
- Hypersensitivity to pramipexole or other dopamine agonists
- Supine blood pressure at screening of systolic<100 mmHg and diastolic < 60 mmHg, or symptomatic orthostatic hypotension (i. .e. clinical symptoms of orthostatic hypotension associated with a decline >=20 mmHg in systolic BP and a decline >=10 mmHg in diastolic BP, at one minute after standing compared to the previous supine systolic and diastolic BP obtained after 5 minutes of quiet rest)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Dose Bioequivalence Study of Pramipexole With Increasing Doses (0.375mg to 1.5mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375mg Extended Release Tablet q.d. Versus 0.125mg Immediate Release (IR) Tablet t.i.d and 1.5 mg Extended Release Tablet q.d. Versus 0.5mg Immediate Release Tablet t.i.d. in Chinese Healthy Male Volunteers
To establish bioequivalence at steady state of:
1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status
To investigate dose proportionality of pharmacokinetics parameters for:
1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.
- Conditions
- Healthy
- Being tested
- pramipexole extended release, pramipexole immediate release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pramipexole extended releaseDrug
0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
pramipexole extended releaseDrug
0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
pramipexole immediate releaseDrug
0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
pramipexole immediate releaseDrug
0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
| Study group | Role | What they receive |
|---|---|---|
| pramipexole extended release | Experimental | 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) Receives: Drug: pramipexole extended release; Drug: pramipexole immediate release |
| pramipexole immediate release | Active comparator | 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) Receives: Drug: pramipexole extended release; Drug: pramipexole immediate release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Measured: 27 days
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Measured: 27 days
Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)
Cmax = maximum observed concentration of the analyte in plasma at steady state
Measured: 27 days
Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)
Cmax,ss = maximum observed concentration of the analyte in plasma at steady state
Measured: 27 days
Secondary outcomes (16)
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)
tmax = time of maximum observed plasma concentration
Measured: 27 days
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)
tmax = time of maximum observed plasma concentration
Measured: 27 days
Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)
PTF = Peak-to-trough fluctuation is measured as a percent
Measured: 27 days
Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)
PTF = Peak-to-trough fluctuation is measured as a percent
Measured: 27 days
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)
Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose
Measured: 27 days
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)
Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose
Measured: 27 days
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)
Cavg = Average concentration of the analyte in plasma at steady state
Measured: 27 days
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)
Cavg = Average concentration of the analyte in plasma at steady state
Measured: 27 days
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)
t1/2,ss - Apparent plasma terminal elimination half-life at steady state
Measured: 27 days
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)
t1/2,ss - Apparent plasma terminal elimination half-life at steady state
Measured: 27 days
Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)
Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state
Measured: 27 days
Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)
Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state
Measured: 27 days
The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)
CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration
Measured: 27 days
The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)
CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration
Measured: 27 days
Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)
Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration
Measured: 27 days
Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)
Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration
Measured: 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214109
- Sponsor's protocol ID
- 248.665
- Status last verified
- Mar 2014
- First submitted
- 1 Oct 2010
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Bioequivalence Study of Pramipexole With Increasing Doses (0.375mg to 1.5mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375mg Extended Release Tablet q.d. Versus 0.125mg Immediate Release (IR) Tablet t.i.d and 1.5 mg Extended Release Tablet q.d. Versus 0.5mg Immediate Release Tablet t.i.d. in Chinese Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01214109
- Acronym / sponsor ID
- 248.665
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Posted 27 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish bioequivalence at steady state of:
1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status
To investigate dose proportionality of pharmacokinetics parameters for:
1)pramipexole extended release dosage of 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 extended release | Experimental | Drug: pramipexole extended release, Drug: pramipexole immediate release0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) |
| pramipexole immediate release | Active comparator | Drug: pramipexole extended release, Drug: pramipexole immediate release0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
- Age older than or equal 18 and Age younger than or equal 40 years
- Body Mass Index larger than or equal 19 and Body Mass Index less than or equal 24kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
Key exclusion criteria (21 listed)
- Any finding of the medical examination (including Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- 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 |
|---|---|---|
| pramipexole extended release0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) | Drug | pramipexole immediate release |
| pramipexole extended release0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) | Drug | pramipexole extended release |
| pramipexole immediate release0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) | Drug | pramipexole immediate release |
| pramipexole immediate release0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) | Drug | pramipexole extended release |
Primary outcome
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)
Time frame: 27 days
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)
Time frame: 27 days
Cmax = maximum observed concentration of the analyte in plasma at steady state
Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Cmax,ss = maximum observed concentration of the analyte in plasma at steady state
16 secondary outcomes
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)
Time frame: 27 days
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)
Time frame: 27 days
Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)
Time frame: 27 days
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)
Time frame: 27 days
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)
Time frame: 27 days
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)
Time frame: 27 days
Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)
Time frame: 27 days
The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)
Time frame: 27 days
Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)
Time frame: 27 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 pramipexole extended release and pramipexole immediate release in people with Healthy, run by Boehringer Ingelheim at 1 site in China.
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 5 inclusion and 21 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 27 Jun 2014. 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 China. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects) (time frame: 27 days). The study lists 4 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 27 Jun 2014.