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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00650312 |
Purpose
The objective of this study is to investigate the bioequivalence of Mylan metformin hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metformin Hydrochloride ER Tablets 500 mg Drug: Glucophage® XR Tablets 500 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| 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 |
| Enrollment: | 50 |
| Study Start Date: | October 2002 |
| Study Completion Date: | November 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Metformin Hydrochloride ER Tablets 500 mg
|
Drug: Metformin Hydrochloride ER Tablets 500 mg
500mg, single dose fasting
|
|
2: Active Comparator
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 |
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. 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) postmenopausal accompanied with a documented postmenopausal course of at least one year or surgical sterility (tubal ligation, oophorectomy or hysterectomy).
Exclusion Criteria:
Institutionalized subjects will not be used. 2 Social Habits:
3. Medications:
Use of hormonal contraceptives and hormonal replacement therapy within three months 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 prestudy 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. 9. History of difficulty in swallowing medication, or any gastrointestinal disorder which could affect the drug absorption.
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: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | METF-0282 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00650312 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Hypoglycemic Agents Physiological Effects of Drugs Metformin Pharmacologic Actions |