Completed PHASE1 INTERVENTIONAL 2-arm NCT00929201

Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

Sponsor: Merck Sharp & Dohme LLC

Conditions Type 2 Diabetes Mellitus

Interventions Metformin hydrochloride Sitagliptin phosphate Sitagliptin phosphate/metformin hydrochloride FDC

Updated 8 times since 2017 Last updated: Jul 22, 2015 Started: Jan 31, 2008 Primary completion: Mar 31, 2008 Completion: May 31, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00929201, this PHASE1 trial focuses on Type 2 Diabetes Mellitus and remains completed. Sponsored by Merck Sharp & Dohme LLC, it has been updated 8 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

8 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE1
Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jun 2022 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Jun 2022 [monthly]

Completed PHASE1

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Jan 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Merck Sharp & Dohme LLC

Data source: Merck Sharp & Dohme LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.