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.
ConditionHealthy
InterventionDrug: Metformin HCl
PhasePhase 1
SponsorTorrent Pharmaceuticals Limited
Responsible PartyTorrent Pharmaceuticals Limited
ClinicalTrials.gov IdentifierNCT00944346
First ReceivedJuly 21, 2009
Last UpdatedJuly 22, 2009
Last verifiedJuly 2009

Tracking Information[ + expand ][ + ]

First Received DateJuly 21, 2009
Last Updated DateJuly 22, 2009
Start DateNot Provided
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleStudy 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
Official TitleNot 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignN/A
ConditionHealthy
InterventionDrug: Metformin HCl
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated EnrollmentNot Provided
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNot Provided
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00944346
Other Study ID Numbers40484
Has Data Monitoring CommitteeNot Provided
Information Provided ByTorrent Pharmaceuticals Limited
Study SponsorTorrent Pharmaceuticals Limited
CollaboratorsNot Provided
Investigators Not Provided
Verification DateJuly 2009

Locations[ + expand ][ + ]

Gateway Medical Research, Inc.
St, Charles, Missouri, United States