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

NCT00944346 | Completed Phase 1

• 1 other identifier: 40484
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Interventions

Metformin HCl DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Condom and topical spermicide
• Condom and diaphragm
• Intra-uterine device (I.U.D)
• Complete abstinence.
• Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Last Updated: July 23, 2009

Record last verified: 2009-07

Locations

US (1)