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

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00650234
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Metformin Hydrochloride ER Tablets 500 mg
Drug: Glucophage® XR Tablets 500 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single-Dose Fasting In Vivo Bioequivalence Study of Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR Tablets (500 mg; Bristol-Myers Squibb) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: February 2004
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Metformin Hydrochloride ER Tablets 500 mg
Drug: Metformin Hydrochloride ER Tablets 500 mg
500mg, single dose fasting
Active Comparator: 2
Glucophage® XR Tablets 500 mg
Drug: Glucophage® XR Tablets 500 mg
500mg, single dose fasting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18 years and older.
  2. Sex: Male and non-pregnant, non-lactating female.

    1. Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on the weekends, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study.
    2. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:

      1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
      2. barrier methods containing or used in conjunction with a spermicidal agent, or
      3. surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
    3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
  3. Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
  4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Social Habits:

    1. Use of any tobacco products within 1 year of the start of the study.
    2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. Positive test for any drug included in the urine drug screen.
  3. Medications:

    1. Use of any prescription or over-the-counter (OTC) medication within the 14 days prior to the initial dose of study medication.
    2. Use of any hormonal contraceptives or hormonal replacement therapy within 3 months prior to the initial dose of study medication.
    3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant chronic disease and/or hepatitis.
    2. History of drug and/or alcohol abuse.
    3. Acute illness at the time of either the pre-study medical evaluation or dosing.
    4. Positive HIV, hepatitis B, or hepatitis C test.
    5. Renal disease or renal dysfunction (as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females) or abnormal creatinine clearance).
  5. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide for Clinically Relevant Abnormalities (see Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing.
  6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
  7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  8. Allergy or hypersensitivity to metformin hydrochloride or other related products.
  9. History of difficulty in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00650234

Locations
United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00650234     History of Changes
Other Study ID Numbers: METF-0412
Study First Received: March 30, 2008
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014