NCT06124547View on ClinicalTrials.gov

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 16, 2023

Primary Completion Date

February 13, 2023

Study Completion Date

February 13, 2023

Conditions
BioequivalenceDiabetes Mellitus, Type 2
Interventions
DRUG

Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet

The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet (Test or reference)

Trial Locations (1)

66260

Avant Santé Research Center S.A. de C.V., San Pedro Garza García

Sponsors

Lead Sponsor

Galenicum Health
All Listed Sponsors
lead

Galenicum Health

INDUSTRY

NCT06124547 - Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions. | Biotech Hunter | Biotech Hunter