Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01214109

First received: October 1, 2010

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: January 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Healthy
Interventions:	Drug: pramipexole extended release Drug: pramipexole immediate release

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented in the milestone are by overall treatment, A, B, C or D.

Reporting Groups

	Description
0.375 mg q.d.Extended Release (ER)	0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
0.125 mg t.i.d. Immediate Release (IR)	0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
1.5 mg q.d. ER	1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
0.5 mg t.i.d. IR	0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole

Participant Flow: Overall Study

	0.375 mg q.d.Extended Release (ER)	0.125 mg t.i.d. Immediate Release (IR)	1.5 mg q.d. ER	0.5 mg t.i.d. IR
STARTED	24	24	24	24
COMPLETED	24	24	24	24
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
All Subjects	No text entered.

Baseline Measures

	All Subjects
Number of Participants [units: participants]	24
Age [units: years] Mean ± Standard Deviation	31 ± 2.2
Gender [units: participants]
Female	0
Male	24

Outcome Measures

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1. Primary:

Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC_0-24,ss); in Case of ER up to the Time Point of Next Doing (AUC_tau,ss) [ Time Frame: 27 days ]

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2. Primary:

Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC_0-24,ss); in Case of ER up to the Time Point of Next Doing (AUC_tau,ss) [ Time Frame: 27 days ]

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3. Primary:

Maximum Steady State Concentration (C_max,ss) [ Time Frame: 27 days ]

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4. Primary:

Maximum Steady State Concentration (C_max,ss) [ Time Frame: 27 days ]

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5. Secondary:

Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (t_max) [ Time Frame: 27 days ]

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6. Secondary:

Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (t_max) [ Time Frame: 27 days ]

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7. Secondary:

Peak-to-trough Fluctuation (PTF) [ Time Frame: 27 days ]

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8. Secondary:

Peak-to-trough Fluctuation (PTF) [ Time Frame: 27 days ]

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9. Secondary:

Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (C_pre,ss) [ Time Frame: 27 days ]

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Measure Type	Secondary
Measure Title	Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (C_pre,ss)
Measure Description	No text entered.
Time Frame	27 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects with values for C_pre,ss

Reporting Groups

	Description
0.375 mg q.d.ER	0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
0.125 mg t.i.d. IR	0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
1.5 mg q.d. ER	1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
0.5 mg t.i.d. IR	0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole

Measured Values

	0.375 mg q.d.ER	0.125 mg t.i.d. IR	1.5 mg q.d. ER	0.5 mg t.i.d. IR
Number of Participants Analyzed [units: participants]	0	0	0	24
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (C_pre,ss) [units: ng/mL] Geometric Mean ( Geometric Coefficient of Variation )				0.507 ( 90.4% )

No statistical analysis provided for Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (C_pre,ss)

10. Secondary:

Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (C_pre,ss) [ Time Frame: 27 days ]

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11. Secondary:

Average Concentration in Plasma Under Steady-state Conditions (C_avg) [ Time Frame: 27 days ]

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12. Secondary:

Average Concentration in Plasma Under Steady-state Conditions (C_avg) [ Time Frame: 27 days ]

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13. Secondary:

Terminal Half-life of the Analyte in Plasma at Steady State (t_1/2,ss) [ Time Frame: 27 days ]

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14. Secondary:

Terminal Half-life of the Analyte in Plasma at Steady State (t_1/2,ss) [ Time Frame: 27 days ]

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15. Secondary:

Minimum Steady State Concentration (C_min,ss) [ Time Frame: 27 days ]

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16. Secondary:

Minimum Steady State Concentration (C_min,ss) [ Time Frame: 27 days ]

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17. Secondary:

The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) [ Time Frame: 27 days ]

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18. Secondary:

The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) [ Time Frame: 27 days ]

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19. Secondary:

Apparent Volume of Distribution During the Terminal Phase at Steady State Following an Extravascular Dose (V_z/F,ss) [ Time Frame: 27 days ]

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20. Secondary:

Apparent Volume of Distribution During the Terminal Phase at Steady State Following an Extravascular Dose (V_z/F,ss) [ Time Frame: 27 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01214109 History of Changes
Other Study ID Numbers:	248.665
Study First Received:	October 1, 2010
Results First Received:	January 25, 2012
Last Updated:	May 18, 2012
Health Authority:	China: Food and Drug Administration

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