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Last Updated: May 19, 2022

CLINICAL TRIALS PROFILE FOR LYRICA


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505(b)(2) Clinical Trials for Lyrica

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01638273 ↗ PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects Completed GL Pharm Tech Corporation Phase 1 2014-02-01 The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation NCT02326987 ↗ A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects Completed GL Pharm Tech Corporation Phase 1 2013-10-01 The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation NCT02327000 ↗ A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers Completed GL Pharm Tech Corporation Phase 1 2014-10-01 The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lyrica

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00142883 ↗ The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3 Terminated National Institute on Drug Abuse (NIDA) N/A 2004-09-01 Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.
NCT00142883 ↗ The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3 Terminated Yale University N/A 2004-09-01 Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.
NCT00280059 ↗ Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy Completed Pfizer Phase 3 2006-08-01 The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
NCT00280059 ↗ Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 3 2006-08-01 The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
NCT00288639 ↗ Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER). Completed Pfizer Phase 4 2005-12-01 The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
NCT00288639 ↗ Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER). Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 4 2005-12-01 The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lyrica

Condition Name

Condition Name for Lyrica
Intervention Trials
Healthy 11
Pain 10
Neuropathic Pain 9
Fibromyalgia 8
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Condition MeSH

Condition MeSH for Lyrica
Intervention Trials
Neuralgia 29
Pain, Postoperative 22
Peripheral Nervous System Diseases 13
Diabetic Neuropathies 11
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Clinical Trial Locations for Lyrica

Trials by Country

Trials by Country for Lyrica
Location Trials
United States 492
India 36
Canada 34
China 25
United Kingdom 21
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Trials by US State

Trials by US State for Lyrica
Location Trials
Florida 26
California 25
Texas 24
New York 22
Pennsylvania 18
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Clinical Trial Progress for Lyrica

Clinical Trial Phase

Clinical Trial Phase for Lyrica
Clinical Trial Phase Trials
Phase 4 39
Phase 3 39
Phase 2/Phase 3 4
[disabled in preview] 41
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Clinical Trial Status

Clinical Trial Status for Lyrica
Clinical Trial Phase Trials
Completed 96
Terminated 19
Unknown status 17
[disabled in preview] 21
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Clinical Trial Sponsors for Lyrica

Sponsor Name

Sponsor Name for Lyrica
Sponsor Trials
Pfizer 54
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 28
Hamilton Health Sciences Corporation 6
[disabled in preview] 14
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Sponsor Type

Sponsor Type for Lyrica
Sponsor Trials
Other 123
Industry 116
NIH 8
[disabled in preview] 3
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