NCT05549570

Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers

Single Dose Crossover Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Film-coated Tablets in Healthy Male and Female Volunteers.

• 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 evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed conditions.

Conditions

• Bioequivalence
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Sitagliptin/Metformin HCl 50/850 mg film-coated tablet	The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/850 mg film-coated tablet

Timeline

• Start date: 2017-10-22
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2022-09-22
• Last updated: 2022-09-22

Locations

1 site across 1 country: Canada