A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Non-fasting Conditions
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is compare the relative bioavailability of 750 mg Metformin Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 750 mg) in healthy adult volunteers under non-fasting conditions |
|---|---|
| Condition | Healthy |
| Intervention | Drug: Metformin HCl 750 mg Extender Release tablets, single dose Drug: GLUCOPHAGE® XR 750 mg tablets, single dose |
| Phase | Phase 1 |
| Sponsor | Actavis Inc. |
| Responsible Party | Actavis Inc. |
| ClinicalTrials.gov Identifier | NCT00865852 |
| First Received | March 18, 2009 |
| Last Updated | August 13, 2010 |
| Last verified | August 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 18, 2009 |
|---|---|
| Last Updated Date | August 13, 2010 |
| Start Date | August 2003 |
| Estimated Primary Completion Date | August 2003 |
| Current Primary Outcome Measures | Rate and Extend of Absorption [Time Frame: 36 hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Non-fasting Conditions |
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| Official Title | A Relative Bioavailability Study of 750 mg Metformin Hydrochloride Extended Release Tablets Under Non-Fasting Conditions |
| Brief Summary | The purpose of this study is compare the relative bioavailability of 750 mg Metformin Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 750 mg) in healthy adult volunteers under non-fasting conditions |
| Detailed Description | Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under non- fasting conditions Official Title: A Relative Bioavailability Study of 750 mg Metformin Hydrochloride Extended Release Tablets Under Non-Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label |
| Condition | Healthy |
| Intervention | Drug: Metformin HCl 750 mg Extender Release tablets, single dose A: Experimental Subjects received Purepac formulated products under non-fasting conditions Other Names: MetforminDrug: GLUCOPHAGE® XR 750 mg tablets, single dose B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under non-fasting conditions Other Names: Metformin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | August 2003 |
| Estimated Primary Completion Date | August 2003 |
| Eligibility Criteria | Inclusion Criteria: 1. Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults -1983 Metropolitan Height and Weight Table. 2. Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures. Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. -The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems. The screening clinical laboratory procedures will include: - HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential; RBC count, platelet count; - CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase; - HIV antibody and hepatitis B surface antigen screens; - URINALYSIS: by dipstick, microscopic examination if dipstick positive; and. - URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine. - SERUM PREGNANCY SCREEN (female volunteers only) 3. If female and: - of childbearing potential, is practicing an acceptable barrier method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm; intrauterine device (IUD), or abstinence; or - is postmenopausal for at least I year; or - is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Exclusion Criteria: 1. Volunteers with a recent history of drug or alcohol addiction or abuse. 2. Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the medical investigator). 3. Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant. 4. Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen. 5. Volunteers demonstrating a positive drug abuse screen when screened for this study. 6. Female volunteers demonstrating a positive pregnancy screen. 7. Female volunteers who are currently breastfeeding. 8. Volunteers with a history of allergic response(s) to metformin or related drugs. 9. Volunteers with a history of clinically significant allergies including drug allergies. 10. Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator). 11. Volunteers who currently use tobacco products. 12. Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism in the 28 days prior to Period I dosing. 13. Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study. 14. Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study. 15. Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing. 16. Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00865852 |
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| Other Study ID Numbers | R03-373 |
| Has Data Monitoring Committee | No |
| Information Provided By | Actavis Inc. |
| Study Sponsor | Actavis Inc. |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: James D. Carlson,, Pharm.D, PRACS Institute, Ltd. |
| Verification Date | August 2010 |
Locations[ + expand ][ + ]
| PRACS Institute, Ltd. | Fargo, North Dakota, United States, 58102 |
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