NCT01214109

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 27, 2012

Completed
Last Updated

June 27, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

October 1, 2010

Results QC Date

January 25, 2012

Last Update Submit

June 17, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    27 days

Secondary Outcomes (16)

  • Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)

    27 days

  • Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)

    27 days

  • Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)

    27 days

  • Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)

    27 days

  • Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)

    27 days

  • +11 more secondary outcomes

Study Arms (2)

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)

Drug: pramipexole extended releaseDrug: 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)

Drug: pramipexole extended releaseDrug: pramipexole immediate release

Interventions

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 release
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 release

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

248.665.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Location

MeSH Terms

Interventions

Pramipexole

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Last Updated

June 27, 2014

Results First Posted

February 27, 2012

Record last verified: 2014-03

Locations

CN(1)