Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00650312 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT00650312 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 50 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00650312, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

The objective of this study is to investigate the bioequivalence of Mylan metformin hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.

Interventions

  • DRUG Metformin Hydrochloride ER Tablets 500 mg
  • DRUG Glucophage® XR Tablets 500 mg

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2002-10
Est. Completion 2002-11
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00650312

The ClinicalTrials.gov registry entry for NCT00650312 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Metformin Hydrochloride ER Tablets 500 mg is the first listed.

NCT00650312 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00650312 about?

NCT00650312 is a clinical study titled "Fasting Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg". The objective of this study is to investigate the bioequivalence of Mylan metformin hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.

What is the current status of trial NCT00650312?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2002-10. Estimated completion is 2002-11.

What interventions are being tested in trial NCT00650312?

The interventions under investigation include: Metformin Hydrochloride ER Tablets 500 mg (DRUG), Glucophage® XR Tablets 500 mg (DRUG).

Who is sponsoring clinical trial NCT00650312?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.