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Pregabalin immediate release

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 22, 2021

Target and mechanism

ModalitySmall molecule

Also known as Pregabalin immediate release, 75mg

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Pregabalin immediate release · 1 trial · 1 indication

Phase 1 1
NCT01257516An 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 In Healthy VolunteersHealthy
COMPLETED18 Analytics
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 In Healthy Volunteers
Healthy
NCT0125751618
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Study Endpoints

Primary Endpoints

Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg)
5 days

Secondary Endpoints

Safety endpoints include evaluation of adverse events
5 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Pregabalin immediate release, 300 mgOTHERReference Treatment
Pregabalin controlled release, 330 mgEXPERIMENTAL -

Interventions

NameTypeDescription
Pregabalin immediate release, 300 mgDRUG300 mg immediate release capsule administered twice daily for four days
Pregabalin controlled release, 330 mgDRUGTwo tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days
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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:Belgium
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