NCT05549583

Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers

Single Dose Crossover Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Film-coated Tablets in Healthy Male and Female Volunteers / Fed State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Galenicum Health · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to determine the bioequivalence of two different formulations of sitagliptin/ metformin after a single oral dose administration under fed conditions.

Conditions

• Bioequivalence
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet	The subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet

Timeline

• Start date: 2018-04-15
• Primary completion: 2018-04-25
• Completion: 2018-04-25
• First posted: 2022-09-22
• Last updated: 2022-09-22

Locations

1 site across 1 country: Canada