Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.

NCT06124560 PHASE1 COMPLETED

The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose administration under fasting conditions.

Details

Lead sponsor	Galenicum Health
Phase	PHASE1
Status	COMPLETED
Enrolment	58
Start date	Fri Oct 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Nov 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Bioequivalence
• Diabetes Mellitus, Type 2

Interventions

• Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet

Countries

Mexico