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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 Fasting Conditions.

NCT06124495 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-11-09

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 sitagliptin/metformin extended release tablets after a single oral dose administration under fasting conditions.

Conditions

  • Bioequivalence
  • Diabetes 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)

Sponsors & Collaborators

  • Galenicum Health

    lead INDUSTRY

Principal Investigators

  • María Elena Cedano Limón, Dr · Avant Santé Research Center S.A. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2023-02-13
Completion
2023-02-13

Countries

  • Mexico

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 NCT06124495 on ClinicalTrials.gov