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Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fast Study.

NCT07763951 · 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

  • Bioequivalance

Interventions

DRUG

Janumet XR

Janumet XR, 100 mg/1000 mg, ER tablet

DRUG

Sitagliptin/Metformin FDC

Sitagliptin/metformin, 100 mg/1000 mg, ER tablet

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
2025-12-03
Primary Completion
2025-12-14
Completion
2025-12-14

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 NCT07763951 on ClinicalTrials.gov