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OpenTrials
Completed

NCT Number: NCT00882882

To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.

Completed

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Key information

Conditions

Type II Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Treatment and study plan

Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Drug

GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 23 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Apr 17, 2009
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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