Completed NA NCT01677260

Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet

A Combined Single Dose Study Under Fasting Condition And Multiple Doses Study Under Normal Diabetic Meal Comparing the Bioavailability of Two Formulations of 500 mg Metformin Hydrochloride Extended Release Tablets.

Sponsor: Dexa Medica Group

Conditions Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose

Interventions 500 mg metformin hydrochloride extended release caplet (test drug) 500 mg metformin hydrochloride prolonged release tablet (reference drug)

Updated 5 times since 2017 Last updated: Aug 30, 2012 Started: Oct 31, 2009 Primary completion: Dec 31, 2009 Completion: Jan 31, 2010

Listed as NCT01677260, this NA trial focuses on Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose and remains completed. Sponsored by Dexa Medica Group, it has been updated 5 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed NA
Jul 2024 — Sep 2024 [monthly]

Completed NA
Jan 2021 — Jul 2024 [monthly]

Completed NA
Jun 2018 — Jan 2021 [monthly]

Completed NA
Jan 2017 — Jun 2018 [monthly]

Completed NA

First recorded

Oct 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Dexa Medica Group

Data source: Dexa Medica Group

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

Study Locations

• Jakarta, Indonesia