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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648518 |
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 750 mg (1 x 750 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metformin Hydrochloride ER Tablets 750 mg Drug: Glucophage® XR Tablets 750 mg |
Phase I |
| 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 (750 mg; Mylan) and Glucophage® XR Tablets (750 mg; Bristol-Myers Squibb) in Healthy Volunteers |
| Enrollment: | 36 |
| Study Start Date: | December 2003 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Metformin Hydrochloride ER Tablets 750 mg
|
Drug: Metformin Hydrochloride ER Tablets 750 mg
750mg, single dose fasting
|
|
Active Comparator: 2
Glucophage® XR Tablets 750 mg
|
Drug: Glucophage® XR Tablets 750 mg
750mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and non-pregnant, non-lactating female.
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.
Exclusion Criteria:
Institutionalized subjects will not be used. 2 Social Habits:
3. Medications:
a. Use of any prescription or over-the-counter (OTC) medication within the 14 days prior to the initial dose of study medication.
b. Use of any hormonal contraceptives and hormonal replacement therapy within 3 months prior to the initial dose of study medication.
c. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
4. Diseases:
a. History of any significant chronic disease and/or hepatitis. b. History of drug and/or alcohol abuse. c. Acute illness at the time of either the pre-study medical evaluation or dosing.
d. Positive HIV, hepatitis B, or hepatitis C test. e. 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:
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| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00648518 History of Changes |
| Other Study ID Numbers: | METF-0363 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |