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A Relative Bioavailability Study of Metformin HCl 500 mg ER Tablets Under Fasting Conditions
NCT00865748 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is compare the relative bioavailability of 500 mg Metformin Hydrochloride Extended Release Tablets by Alpharma with that of 500 mg CLUCOPHAGE® XR Tablets distributed by Bristol-Myers Squibb Company following a single oral dose (1 x 500 mg extended-release tablet) in healthy adult volunteers under fasting conditions.
Conditions Studied
Interventions
- DRUG Metformin HCl 500 mg tablets, single dose
- DRUG CLUCOPHAGE® XR 500 mg tablets, single dose
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. — Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-01 |
| Est. Completion | 2004-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00865748
The ClinicalTrials.gov registry entry for NCT00865748 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions — of which Metformin HCl 500 mg tablets, single dose is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00865748 reports 1 study location spanning 1 distinct geographic area — top geographies include North Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00865748 about?
NCT00865748 is a clinical study titled "A Relative Bioavailability Study of Metformin HCl 500 mg ER Tablets Under Fasting Conditions". The purpose of this study is compare the relative bioavailability of 500 mg Metformin Hydrochloride Extended Release Tablets by Alpharma with that of 500 mg CLUCOPHAGE® XR Tablets distributed by Bristol-Myers Squibb Company following a single oral dose (1 x 500 mg extended-release tablet) in healthy...
What is the current status of trial NCT00865748?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-01. Estimated completion is 2004-01.
What conditions does trial NCT00865748 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00865748?
The interventions under investigation include: Metformin HCl 500 mg tablets, single dose (DRUG), CLUCOPHAGE® XR 500 mg tablets, single dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00865748?
This trial is sponsored by Actavis, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00865748 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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