Bioequivalence of Pramipexole Extended Release (PPX ER) 1... | NCT01119443

NCT01119443

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Drug: PPX ER

Name	Type	Description	Arm Group Labels	Other Names
PPX ER	Drug	PPX ER 0.375mg - 1.5mg for 32 days totally	Treatment sequence A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCτ,ss (Fed Conditions)	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ	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	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	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	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

Measure	Description	Time Frame
Cτ,ss (Fed Conditions)	Concentration of the analyte in plasma at time τ at steady state	pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration
Cmin,ss (Fed Conditions)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

References Module

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IPD Sharing Statement Module

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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment Sequence A	1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
FG001	Treatment Sequence B

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

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Intervention Browse Module

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Masking Info

Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted

FG00014 subjects
FG00114 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Treatment Sequence A	1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
BG001	Treatment Sequence B	0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00014 BG00114 BG00228

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00033.7± 5.89 OG00132.3± 5.89

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA				Test/Reference Ratio of the mean x 100	104.2			2-Sided	90	98.3	110.3			Bioequivalence is established when 90% Confidence Interval falls within 80 - 125	Yes	Non-Inferiority or Equivalence	Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition

Primary

Cmax,ss (Fed Conditions)

maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

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

Posted

Geometric Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions

Units	Counts
Participants	OG000

Secondary

Cτ,ss (Fed Conditions)

Concentration of the analyte in plasma at time τ at steady state

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

Posted

Geometric Mean

Standard Error

ng/mL

pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions

Units	Counts
Participants	OG000

Secondary

Cmin,ss (Fed Conditions)

Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

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

Posted

Geometric Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions

Units	Counts
Participants	OG000

Secondary

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

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

Posted

Mean

Full Range

hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions

Units	Counts
Participants	OG000

Secondary

λz,ss (Fed Conditions)

Terminal rate constant of the analyte in plasma at steady state

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

Posted

Geometric Mean

Standard Deviation

per hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions

Units	Counts
Participants	OG000

Secondary

t1/2,ss (Fed Conditions)

Terminal half-life of the analyte in plasma at steady state

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

Posted

Geometric Mean

Standard Deviation

hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions

Units	Counts
Participants	OG000

Secondary

MRTpo,ss (Fed Conditions)

Mean residence time of the analyte in the body at steady state after oral administration

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

Posted

Geometric Mean

Standard Deviation

hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions

Units	Counts
Participants	OG000

Primary

AUCτ,ss (Fasted Conditions)

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ

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

Posted

Geometric Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Primary

Cmax,ss (Fasted Conditions)

maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

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

Posted

Geometric Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Secondary

Cτ,ss (Fasted Conditions)

Concentration of the analyte in plasma at time τ at steady state

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

Posted

Geometric Mean

Standard Error

ng/mL

pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Secondary

Cmin,ss (Fasted Conditions)

Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

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

Posted

Geometric Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Secondary

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

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

Posted

Mean

Full Range

hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Secondary

λz,ss (Fasted Conditions)

Terminal rate constant of the analyte in plasma at steady state

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

Posted

Geometric Mean

Standard Deviation

/hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Secondary

t1/2,ss (Fasted Conditions)

Terminal half-life of the analyte in plasma at steady state

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

Posted

Geometric Mean

Standard Deviation

hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Secondary

MRTpo,ss (Fasted Conditions)

Mean residence time of the analyte in the body at steady state after oral administration

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

Posted

Geometric Mean

Standard Deviation

hour

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

ID	Title	Description
OG000	Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted	Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
OG001	Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted	Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Up-titration	Up-titration to 0.75mg (10 days)	28	5	28
EG001	1.5 mg q.d. Fed	1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fed condition (10days in crossover)	28	5	28
EG002	1.5 mg q.d. Fast	1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fast condition (10 days in crossover)	27	0	27

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Somnolence	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected28 at risk EG0012 affected28 at risk EG0020 affected27 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected28 at risk EG0012 affected28 at risk EG0020 affected27 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected28 at risk EG0012 affected28 at risk EG0020 affected27 at risk