Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects
Overview[ - collapse ][ - ]
Purpose | - Objective: - A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects. - Study Design: - Randomized,single-dose,2-way crossover. |
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Condition | Healthy |
Intervention | Drug: Metformin HCl |
Phase | Phase 1 |
Sponsor | Torrent Pharmaceuticals Limited |
Responsible Party | Torrent Pharmaceuticals Limited |
ClinicalTrials.gov Identifier | NCT00944346 |
First Received | July 21, 2009 |
Last Updated | July 22, 2009 |
Last verified | July 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | July 21, 2009 |
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Last Updated Date | July 22, 2009 |
Start Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Not Provided |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects |
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Official Title | Not Provided |
Brief Summary | - Objective: - A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects. - Study Design: - Randomized,single-dose,2-way crossover. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | N/A |
Condition | Healthy |
Intervention | Drug: Metformin HCl |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - Subject is at least 18 years old. - Subject had no clinically significant abnormal lab values at the screening evaluation. - Subject's drugs of abuse, Hepatitis B, Hepatitis C, and HIV screenings were negative or non-relative. - Acceptable screening of ECG. - Female subject's pregnancy test at screening is negative. - Subject had no evidence of underlying disease at the pre-entry physical examination. - Subject has given written consent to participate. - Female subject has not received any injectable or implantable contraceptive for a period of six months preceding this study. - Agreed to undergo at least a 14-day pre-dose washout. - Beginning two weeks prior to dosing and throughout the study, female subject of childbearing potential agrees to utilize one of the following methods of contraception: 1. Condom and topical spermicide 2. Condom and diaphragm 3. Intra-uterine device (I.U.D) 4. Complete abstinence. - Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods. Exclusion Criteria: - History of treatment for alcoholism, substance abuse, or drug abuse with in the past 24 months. - History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness. - History of GRD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease. - History of treatment for asthma, hypoxemia, dehydration, sepsis, metabolic acidosis and congestive heart failure. - Subject is pregnant or lactating. - History of drug hyper sensitivity. - Subject was treated with any investigational drug during the four weeks prior to initial dosing for the study. - Subject smokes more then 15 cigarettes per day or uses tobacco products or currently uses nicotine products. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Not Provided |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00944346 |
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Other Study ID Numbers | 40484 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Torrent Pharmaceuticals Limited |
Study Sponsor | Torrent Pharmaceuticals Limited |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | July 2009 |
Locations[ + expand ][ + ]
Gateway Medical Research, Inc. | St, Charles, Missouri, United States |
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