HealthyPhase 1NCT01119443

Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers

A Phase 1 study testing PPX ER in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 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?: PPX ER
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteJapan
Study dates: Apr 2010to Jun 2010
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 20 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Japanese healthy male
20 to 40 years of age
body mass index (BMI) between 17.6 and 26.4 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)

Who cannot join

Any clinical relevance findings of the medical examination as follows
Blood pressure (systolic blood pressure is lower than 110 mmHg and diastolic blood pressure is lower than 60 mmHg at the screening in either a supine or a sitting position),
pulse rate,
electrocardiogram [ECG]
laboratory test parameters) of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Show all 9Show fewer

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 acute infections

Trial locations and contacts

1 site in 1 country.

Japan1 site

248.677.001 Boehringer Ingelheim Investigational Site
Sumida-ku, Tokyo

Other trials in Japan

About this study

Official title: A Multiple Dose Study With Increasing Dose for Pramipexole Extended Release (ER) Tablet (0.375 mg q.d. to 1.5 mg q.d.) in Two-way Cross-over Comparison to Investigate the Bioequivalence of 1.5 mg ER x 1 Tablet q.d. Versus 0.375 mg ER x 4 Tablets q.d. Under Fasted and Fed Conditions in Japanese Healthy Male Volunteers

Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.

Conditions: Healthy
Being tested: PPX ER

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PPX ERDrug
PPX ER 0.375mg - 1.5mg for 32 days totally
PPX ERDrug
PPX ER 0.375mg - 1.5mg for 32 days totally

Study groups in NCT01119443
Study group	Role	What they receive
Treatment sequence A	Other	V4: PPX ER 1.5mg x 1 fed, V5: PPX ER 0.375mg x 4 fed, V6:: PPX ER 1.5mg x 1 fasted, V5: PPX ER 0.375mg x 4 fasted Receives: Drug: PPX ER
Treatment sequence B	Other	V4: PPX ER 0.375mg x 4 fed, V5: PPX ER 1.5mg x 1 fed, V6:: PPX ER 0.375mg x 4 fasted, V5: PPX ER 1.5mg x 1 fasted Receives: Drug: PPX ER

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCτ,ss (Fed Conditions)
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Cmax,ss (Fed Conditions)
maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
AUCτ,ss (Fasted Conditions)
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Cmax,ss (Fasted Conditions)
maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration

Secondary outcomes (12)

Cτ,ss (Fed Conditions)
Concentration of the analyte in plasma at time τ at steady state
Measured: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration
Cmin,ss (Fed Conditions)
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Tmax,ss (Fed Conditions)
Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
λz,ss (Fed Conditions)
Terminal rate constant of the analyte in plasma at steady state
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
t1/2,ss (Fed Conditions)
Terminal half-life of the analyte in plasma at steady state
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
MRTpo,ss (Fed Conditions)
Mean residence time of the analyte in the body at steady state after oral administration
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Cτ,ss (Fasted Conditions)
Concentration of the analyte in plasma at time τ at steady state
Measured: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration
Cmin,ss (Fasted Conditions)
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Tmax,ss (Fasted Conditions)
Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
λz,ss (Fasted Conditions)
Terminal rate constant of the analyte in plasma at steady state
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
t1/2,ss (Fasted Conditions)
Terminal half-life of the analyte in plasma at steady state
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
MRTpo,ss (Fasted Conditions)
Mean residence time of the analyte in the body at steady state after oral administration
Measured: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2010

First posted7 May 2010 (estimated)
Study startApr 2010
Primary completionJun 2010

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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01119443
Sponsor's protocol ID: 248.677
Status last verified: May 2014
First submitted: 5 May 2010
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Study With Increasing Dose for Pramipexole Extended Release (ER) Tablet (0.375 mg q.d. to 1.5 mg q.d.) in Two-way Cross-over Comparison to Investigate the Bioequivalence of 1.5 mg ER x 1 Tablet q.d. Versus 0.375 mg ER x 4 Tablets q.d. Under Fasted and Fed Conditions in Japanese Healthy Male Volunteers
ClinicalTrials.gov ID: NCT01119443
Acronym / sponsor ID: 248.677
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jun 2010 (actual)
First posted: 7 May 2010 (estimated)
Results: Posted 27 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment sequence A	Other	Drug: PPX ERV4: PPX ER 1.5mg x 1 fed, V5: PPX ER 0.375mg x 4 fed, V6:: PPX ER 1.5mg x 1 fasted, V5: PPX ER 0.375mg x 4 fasted
Treatment sequence B	Other	Drug: PPX ERV4: PPX ER 0.375mg x 4 fed, V5: PPX ER 1.5mg x 1 fed, V6:: PPX ER 0.375mg x 4 fasted, V5: PPX ER 1.5mg x 1 fasted

Who may qualify

Ages: 20 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Japanese healthy male
20 to 40 years of age
body mass index (BMI) between 17.6 and 26.4 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)

Key exclusion criteria (9 listed)

Any clinical relevance findings of the medical examination as follows
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 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
PPX ERPPX ER 0.375mg - 1.5mg for 32 days totally	Drug	Treatment sequence A
PPX ERPPX ER 0.375mg - 1.5mg for 32 days totally	Drug	Treatment sequence B

Primary outcome

AUCτ,ss (Fed Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Cmax,ss (Fed Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
AUCτ,ss (Fasted Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Cmax,ss (Fasted Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

12 secondary outcomes

Cτ,ss (Fed Conditions)
Time frame: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration
Cmin,ss (Fed Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Tmax,ss (Fed Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
λz,ss (Fed Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
t1/2,ss (Fed Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
MRTpo,ss (Fed Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Cτ,ss (Fasted Conditions)
Time frame: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration
Cmin,ss (Fasted Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Tmax,ss (Fasted Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
λz,ss (Fasted Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
t1/2,ss (Fasted Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
MRTpo,ss (Fasted Conditions)
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration

Results and safety

Results posted to the registry on 27 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence A	14	14
Treatment Sequence B	14	14

Primary outcome: AUCτ,ss (Fed Conditions)

Time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration. Geometric mean (Standard Deviation). Unit: ng·h/mL

Measure	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed n = 27	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed n = 27
Value	33.7 (5.89)	32.3 (5.89)

Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed vs Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed: Test/Reference Ratio of the mean x 100: 104.2 (90% CI 98.3 to 110.3), ANOVA

Population analysed: One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set

Primary outcome: Cmax,ss (Fed Conditions)

Measure	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed n = 27	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed n = 27
Value	2.24 (0.290)	2.13 (0.255)

Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed vs Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed: Test/Reference Ratio of the mean x 100: 104.8 (90% CI 100.1 to 109.8), ANOVA

Population analysed: One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set

Primary outcome: AUCτ,ss (Fasted Conditions)

Measure	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted n = 27	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted n = 27
Value	31.4 (7.37)	33.6 (5.80)

Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted vs Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted: Test/Reference Ratio of the mean x 100: 93.6 (90% CI 86.9 to 100.8), ANOVA

Population analysed: One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set

Primary outcome: Cmax,ss (Fasted Conditions)

Measure	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted n = 27	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted n = 27
Value	2.13 (0.359)	2.12 (0.305)

Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted vs Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted: Test/Reference Ratio of the mean x 100: 100.2 (90% CI 94.0 to 106.7), ANOVA

Population analysed: One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 32 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Up-titration	0 of 28 (0%)	5 of 28 (17.9%)	Not reported
1.5 mg q.d. Fed	0 of 28 (0%)	5 of 28 (17.9%)	Not reported
1.5 mg q.d. Fast	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 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 PPX ER in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

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 3 inclusion and 9 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 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 Japan. 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 Jun 2011). 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?

AUCτ,ss (Fed Conditions) (time frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration). 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?

On the ClinicalTrials.gov record for NCT01119443.

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 Jun 2014.