Clinical trials: Gabapentin
Healthy
A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Non-fasting Conditions
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis following a single oral dose (1 x 800 mg) in…
- Trial name
- NCT00865059
- Testing
- Gabapentin 800 mg Tablets, single dose, NEURONTIN® 800 mg Tablets, single dose
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
RLS
A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633657)
- Testing
- HORIZANT 300 mg
- Where
- 4 sites in United States
- Sponsor
- XenoPort, Inc.
Healthy
Bioequivalence Study of Gabapentin 400 mg Capsules Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg dose under fasting conditions
- Trial name
- NCT00778271
- Testing
- Gabapentin 400mg capsules
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Abuse Potential
Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users
This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6 treatment, 6-period crossover single-dose, Williams square design study in healthy male and/or female adult, non-drug-dependent recreational…
- Trial name
- NCT05319756
- Testing
- gabapentin 600 mg, gabapentin 1200 mg, gabapentin 600 mg and oxycodone HCl 20 mg
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Viatris Specialty LLC
Patients With Impaired Renal Function and Haemodialysis
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
- Trial name
- NCT02629224
- Testing
- ASP8825
- Where
- 2 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Astellas Pharma Inc
Chronic Pain
Efficacy and Safety Study of Gabapentin as add-on to Morphine in Paediatric Patients Affected by Chronic Pain
The objective of the study is to evaluate the efficacy of gabapentin as adjunctive therapy to morphine in the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age assessed…
- Trial name
- GABA-2 (NCT03275012)
- Testing
- Gabapentin + Morphine
- Sponsor
- Pharmaceutical Research Management srl
Painful Diabetic Neuropathy
Trazodone in Painful Diabetic Neuropathy
The aim of the study is to collect preliminary information on the effect of low doses of trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the neuropathic pain symptoms, anxiety, sleep…
- Trial name
- NCT03202979
- Testing
- Trazodone 20 mg, Trazodone 10 mg
- Where
- 20 sites in Czechia, Hungary and 1 more
- Volunteers
- 142 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Insomnia
A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol
- Trial name
- NCT00666796
- Testing
- Ethanol, Gabapentin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal…
- Trial name
- NCT01888497
- Testing
- Gabapentin, Diphenhydramine citrate, Triazolam
- Where
- 4 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
No Condition
A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males
Part A The primary objective of this study is to determine the single dose pharmacokinetics (PK) of ketoprofen lysine salt combined with gabapentin (KLS-GABA [80 mg-34 mg]) compared to KLS alone (80 mg) in healthy male subjects.
- Trial name
- NCT04802967
- Testing
- Ketoprofen Lysine Salt combined with Gabapentin, Ketoprofen Lysine Salt, Gabapentin
- Where
- United Kingdom
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Dompé Farmaceutici S.p.A
Restless Legs Syndrome
Specified Drug Use-Results Survey of Regnite
This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.
- Trial name
- NCT01887613
- Testing
- Regnite
- Where
- 7 sites in Japan
- Volunteers
- 1,597 people
- Sponsor
- Astellas Pharma Inc
Restless Legs Syndrome (RLS)
Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects
This is a double-blind, placebo-and active-controlled 3-period crossover study designed to assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.
- Trial name
- NCT01411124
- Testing
- gabapentin enacarbil, diphenhydramine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- XenoPort, Inc.
Transient Insomnia
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.
- Trial name
- NCT00674752
- Testing
- Gabapentin
- Where
- 4 sites in United States
- Volunteers
- 377 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Restless Legs Syndrome
XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00333359
- Testing
- XP13512 (GEn)
- Volunteers
- 581 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.
- Trial name
- NCT00748098
- Testing
- GSK1838262 Extended Release Tablets
- Where
- 24 sites in United States
- Volunteers
- 136 people
- Sponsor
- XenoPort, Inc.
Transient Insomnia
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
- Trial name
- NCT00666575
- Testing
- Gabapentin
- Where
- 23 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsy
Bioequivalence Study of 300 mg Gabapentin
The objective of this study was to confirm if two formulations of gabapentin (capsules) are bioequivalent. Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product Nerotin® 300 mg (Pfizer).
- Trial name
- NCT01738893
- Testing
- Gabapentin 300 mg
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Abuse Potential
Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users
The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.
- Trial name
- NCT06247488
- Testing
- Oxycodone 20 mg, GE-IR 200 mg, GE-IR 450 mg
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Arbor Pharmaceuticals, Inc.
Focal Epilepsy
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination…
- Trial name
- NCT00855738
- Testing
- Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
- Volunteers
- 111 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Post Herpetic Neuralgia
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
- Trial name
- NCT01426230
- Where
- 37 sites in United States
- Volunteers
- 201 people
- Sponsor
- Depomed