NCT01821235View on ClinicalTrials.gov

Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Epilepsy and Neuropathic Pain
Interventions
DRUG

Neurontin® (gabapentin) batch A

Neurontin® 800 mg tablets (gabapentin) batch A, given 2 times

DRUG

Neurontin® (gabapentin) batch B

Neurontin® 800 mg tablets (gabapentin) batch B, given 1 time

DRUG

Gabasandoz® (gabapentin) batch A

Gabasandoz® 800 mg tablets (gabapentin) batch A, given 2 times

DRUG

Gabasandoz® (gabapentin) batch B

Gabasandoz® 800 mg tablets (gabapentin) batch A, given 1 time

Trial Locations (1)

9000

Drug Research Unit Ghent (D.R.U.G.), Ghent

All Listed Sponsors
collaborator

Amsterdam UMC, location VUmc

OTHER

collaborator

University Ghent

OTHER

lead

University Hospital, Ghent

OTHER

NCT01821235 - Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers | Biotech Hunter | Biotech Hunter