Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

Summary

The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.

Timeline

Start

2007-10

Primary completion

2007-12

Completion

2008-09

Outcome

Mixed primary results

paper Formal bioequivalence could not be demonstrated for metformin Cmax. PMID 19356391 ↗

paper the extent of exposure to metformin, as reflected by AUC0-12 and AUC0- yen, allows the claim of bioequivalence PMID 19356391 ↗

Publications

• Results Rocha JF, Vaz-da-Silva M, Almeida L, Falcao A, Nunes T, Santos AT, Martins F, Fontes-Ribeiro C, Macedo T, Soares-da-Silva P. Effect of eslicarbazepine acetate on the pharmacokinetics of metformin in healthy subjects. Int J Clin Pharmacol Ther. 2009 Apr;47(4):255-61. doi: 10.5414/cpp47255.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eslicarbazepine acetate	Unknown	1200 mg	Oral
Subject	Metformin	Small molecule	850 mg	—

Indications