Bioequivalence Study of 300 mg Gabapentin

Status Completed

Clinical Trial Summary

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). One capsule was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 26 healthy volunteers, both genders, adults between 18-55 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Epilepsy

Clinical Trial Details

NCT number	NCT01738893
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	January 14, 2011
Completion date	January 22, 2011

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