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Pregabalin controlled release

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 29, 2021

Target and mechanism

ModalitySmall molecule

Also known as Pregabalin controlled release, 400 to 500 calorie, Pregabalin controlled release, 600- 750 calorie, Pregabalin controlled release, low-fat, Pregabalin controlled release, 400 to 500 calories

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials10
Total Enrollment232

FDA Designations

No designations recorded

Clinical trial landscape

Pregabalin controlled release · 10 trials · 1 indication

Phase 1 10
NCT01342198An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release TabletHealthy
COMPLETED18 Analytics
NCT01321671Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy VolunteersHealthy
COMPLETED24 Analytics
NCT01257529An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy VolunteersHealthy
COMPLETED28 Analytics
NCT01270815An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy VolunteersHealthy
COMPLETED28 Analytics
NCT01291524Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy VolunteersHealthy
COMPLETED24 Analytics
NCT01220219An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy VolunteersHealthy
COMPLETED24 Analytics
NCT01202422An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin CapsuleHealthy
COMPLETED24 Analytics
NCT01202435An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin CapsuleHealthy
COMPLETED18 Analytics
NCT01080612A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release FormulationHealthy
COMPLETED24 Analytics
NCT01009541An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin CapsuleHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
Healthy
NCT0134219818
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PHASE1COMPLETED
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Healthy
NCT0132167124
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PHASE1COMPLETED
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Healthy
NCT0125752928
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PHASE1COMPLETED
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Healthy
NCT0127081528
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PHASE1COMPLETED
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Healthy
NCT0129152424
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PHASE1COMPLETED
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
Healthy
NCT0122021924
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PHASE1COMPLETED
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule
Healthy
NCT0120242224
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PHASE1COMPLETED
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule
Healthy
NCT0120243518
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PHASE1COMPLETED
A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation
Healthy
NCT0108061224
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PHASE1COMPLETED
An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule
Healthy
NCT0100954120
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Study Endpoints

Primary Endpoints

Area under the curve from 0 to infinity (AUCinf)
3 days
Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin
3 days
Area under the curve from 0 to infinity (AUCinf) and peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) fed and CR fasted
3 days
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatment
3 days
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
3 days
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 165 mg CR and 75 mg IR (total daily dose 150 mg)
5 days
AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 82.5 mg CR (two tablets administered concurrently) and 165 mg CR
5 days
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR and 150 mg IR (total daily dose 300 mg)
5 days
AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 165 mg CR (two tablets administered concurrently) and 330 mg CR
5 days
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 82.5 mg CR and 25 mg IR capsule given 3 times daily (total daily dose 75 mg)
5 days
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
3 days
Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ
5 days
Minimum plasma concentration at steady-state within a dosing interval (Cmin)
5 days
Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)
5 days
The average plasma concentration at steady-state (Cav), half-life
5 days
Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)
5 days

Secondary Endpoints

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
3 days
Safety endpoints include evaluation of adverse events.
5 days
Safety endpoints include evaluation of adverse events
5 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALSingle Dose Pregabalin Controlled Release
2EXPERIMENTALSingle Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin
Pregabalin controlled release, 330 mg, 600- 750 calorieEXPERIMENTAL -
Pregabalin controlled release, 330 mg, fastedEXPERIMENTAL -
Pregabalin immediate release, 300 mgOTHER -
Pregabalin controlled release, 330 mg, low-fatEXPERIMENTAL -
Pregabalin controlled release, 330 mg, medium-fatEXPERIMENTAL -
Pregabalin controlled release, 330 mg, high-fatEXPERIMENTAL -
Pregabalin controlled release, 330 mg, 400 to 500 caloriesEXPERIMENTAL -
Pregabalin controlled release, 330 mg, 600 to 750 caloriesEXPERIMENTAL -
Pregabalin controlled release, 330 mg, 800 to 1000 caloriesEXPERIMENTAL -
Pregabalin controlled release, 330 mg, 400-500 calorieEXPERIMENTAL -
Pregabalin controlled release, 330 mg, bedtimeEXPERIMENTAL -
Pregabalin controlled release, 82.5 mgEXPERIMENTAL -
Pregabalin controlled release, 165 mgEXPERIMENTAL -
Pregabalin immediate release, 75mgOTHERReference Treatment
Pregabalin controlled release, 330 mgEXPERIMENTAL -
Pregabalin immediate release, 150 mgOTHERReference Treatment
Pregabalin immediate release, 25 mgOTHERReference Treatment
330 mg pregabalin controlled release: 400 to 500 caloriesEXPERIMENTAL -
330 mg pregabalin controlled release: 600 to 750 caloriesEXPERIMENTAL -
330 mg pregabalin controlled release: 800 to 1000 caloriesEXPERIMENTAL -
300 mg pregabalin immediate releaseOTHER -

Interventions

NameTypeDescription
Pregabalin controlled release, 330 mgDRUGA single oral dose of 330 mg controlled release tablet
erythromycinDRUGA total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
Pregabalin controlled release, 330 mg, 600- 750 calorieDRUGA single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
Pregabalin controlled release, 330 mg, fastedDRUGA single oral dose of 330 mg controlled release tablet administered fasted in the evening
Pregabalin immediate release, 300 mgDRUGA single oral dose of 300 mg immediate release capsule administered in the evening
Pregabalin controlled release, 330 mg, low-fatDRUGA single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal
Pregabalin controlled release, 330 mg, medium-fatDRUGA single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal
Pregabalin controlled release, 330 mg, high-fatDRUGA single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal
Pregabalin controlled release, 330 mg, 400 to 500 caloriesDRUGA single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch
Pregabalin controlled release, 330 mg, 600 to 750 caloriesDRUGA single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch
Pregabalin controlled release, 330 mg, 800 to 1000 caloriesDRUGA single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch
Pregabalin controlled release, 330 mg, 400 to 500 calorieDRUGA single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal
Pregabalin controlled release, 330 mg, bedtimeDRUGA single oral dose of 330 mg controlled release tablet administered at bedtime
Pregabalin controlled release, 82.5 mgDRUGTwo tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.
Pregabalin controlled release, 165 mgDRUG165 mg controlled release tablet administered once daily for four days.
Pregabalin immediate release, 75mgDRUG75 mg immediate release capsule administered every 12 hours for four days
Pregabalin immediate release, 150 mgDRUG150 mg immediate release capsules administered every 12 hours for four days
Pregabalin immediate release, 25 mgDRUG25 mg immediate release capsules administered three times daily for four days
330 mg pregabalin controlled releaseDRUGA single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
300 mg pregabalin immediate releaseDRUGA single dose of 300 mg immediate release capsule will be administered in the fasted state
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or females * Between the ages of 18 and 55 years, inclusive * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 Exclusion Criteria: * Illicit drug use * Pregnant or nursing females * Females of childbearing potential who are unwilling or unable to use an acceptable me...

Countries:BelgiumUnited States
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