MedTrace Logo

Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 50 mg/1000 mg in Healthy Subjects, Fed Study.

NCT07763912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-08-14

No results posted yet for this study

Summary

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study

Conditions

  • Bioequivalence

Interventions

DRUG

Janumet XR

Janumet XR, 50 mg/1000 mg, ER tablet, reference

DRUG

Sitagliptin/Metformin FDC

Sitagliptin/metformin, ER tablet, 50 mg/1000 mg

Sponsors & Collaborators

  • ADIUM

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2025-12-05
Completion
2025-12-05

Countries

  • Mexico

Study Locations

More Related Trials

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 NCT07763912 on ClinicalTrials.gov