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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00650234
• Date of registration: 30/03/2008
• Primary sponsor: Mylan Pharmaceuticals
• Public title: Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg
• Scientific 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
• Date of first enrolment: February 2004
• Target sample size: 47
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00650234
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Dorian Williams, M.D.
• Affiliation: Kendle International Inc.

Key inclusion & exclusion 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 (ß-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 (ß-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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Glucophage® XR Tablets 500 mg

Drug: Metformin Hydrochloride ER Tablets 500 mg

Primary Outcome(s)

Bioequivalence [Time Frame: within 30 days]

Secondary ID(s)

METF-0412

Source(s) of Monetary Support

Please refer to primary and secondary sponsors