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

NCT05549570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-09-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Galenicum Health

    lead INDUSTRY

Principal Investigators

  • Eric Sicard · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-22
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549570 on ClinicalTrials.gov