Sitagliptin product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of sitagliptin.

Keywords: Bioequivalence, generics, sitagliptin

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current version - effective 1 January 2026

Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance - Revision 1

AdoptedReference Number: EMA/188381/2025/Rev. 1Legal effective date: 01/01/2026

Document history

Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/158934/2016Legal effective date: 01/11/2016Summary:

This document provides product-specific guidance on demonstration of bioequivalence of sitagliptin

Overview of comments on Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance

Reference Number: EMA/CHMP/162917/2016Summary:

Overview of comments on Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance (EMA/CHMP/PKWP/36869/2015)

Draft sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 15/07/2015 to 01/11/2015Reference Number: EMA/CHMP/PKWP/36869/2015Summary:

The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for generic medicines across all authorisation routes available in the European Union. This guidance document describes the specific requirements for the demonstration of bioequivalence for sitagliptin.